NOVARTIS EXHIBIT 2100
`Par v Novartis, IPR 2016-00084
`Page 1 of 4
`
`

`
`NOVARTIS EXHIBIT 2100
`Par v Novartis, IPR 2016-00084
`Page 2 of 4
`
`

`
`2422
`
`Whitehall—Cont.
`
`RIOPAN PLUS® OTC
`[rf'opan ]
`magaldrate and simethicone
`Antacid Plus Anti-Gas
`
`DESCRIPTION
`Riopan Plus is a buffer antacid plus anti-gas combination
`product containing the unique chemical entity Magaldrate.
`Each teaspoonful (6mL) of suspension contains Magaldrate,
`540 mg and Simethicone, 40 mg. Each Chew Tablet contains
`Magaldrate, 480 mg and Simethicone, 20 mg. Riopan Plus
`is considered dietetically sodium-free [containing not more
`than 0.013 mEq. (0.3 mg.) sodium per teaspoonful or 0.004
`mEq. (0.1 mg.) sodium per tablet.]
`ACTIONS
`The active antacid ingredient in Riopan Plus, Magaldrate,
`demonstrates a rapid and uniform buffering action. The
`acid-neutralizing capacity of Riopan Plus is 15.0 mEq per
`5mL and 13.5 mEq per tablet. Riopan Plus does not produce
`acid rebound or alkalinization. Simethicone reduces the
`surface tension of gas bubbles so that the gas is more easily
`eliminated.
`INDICATIONS
`RIOPAN Plus is indicated for the relief of heartburn, sour
`stomach and acid indigestion accompanied by the symptoms
`of gas. For symptomatic relief of hyperacidity associated
`with the diagnosis of peptic ulcer, gastritis, peptic esophagi-
`tis, gastric hyperacidity, hiatal hernia, and postoperative gas
`pain.
`DOSAGE AND ADMINISTRATION
`RIOPAN PLUS (magaldrate and simethicone) Antacid Plus
`Anti-Gas Suspension—Take one or two teaspoonfuls be-
`tween meals and at bedtime, or as directed by the physician.
`RIOPAN PLUS Antacid Plus Anti-Gas Chew Tablets —Chew
`one or two tablets, between meals and at bedtime, or as di-
`rected by the physician.
`WARNINGS
`Patients should not take more than 12 teaspoonfuls, or 25
`tablets, in a 24-hour period or use the maximum dosage for
`more than two weeks, except under the advice and super-
`vision of a physician. If you have kidney disease, do not use
`this product except under the advice and supervision of a
`physician.
`DRUG INTERACTION PRECAUTION
`Do not use in patients presently taking a prescription antibi-
`otic drug containing any form of tetracycline.
`INACTIVE INGREDIENTS
`Chew Tablets: Flavor, Magnesium Stearate, Methylcellu-
`lose, Polyethylene Glycol, Silica, Sorbitol, Starch, Sucrose,
`Titanium Dioxide. Suspension: Flavor, Glycerin, PEG-8
`Stearate, Potassium Citrate, Saccharin, Sorbitan Stearate,
`Sorbitol, Xanthan Gum, Water.
`HOW SUPPLIED
`RIOPAN PLUS Antacid Plus Anti-Gas Suspension —in 12 fl
`oz (355 mL) plastic bottles. Individual Cups, 1 fl oz (30 mL)
`ea., tray of 10—10 trays per packer.
`Store at room temperature (approximately 25*C). Avoid
`freezing.
`RIOPAN PLUS Antacid Plus Anti-Gas Chew Tablets—in
`bottles of 60 and 100. Also single roll packs of 12 tablets and
`3-roll rollpacks of 36 tablets.
`Shown in Product Identification Section, page 434
`
`RIOPAN PLUS® 2 OTC
`[rf'opan plus 2]
`magaldrate and simethicone Double Strength Antacid plus
`Anti-Gas
`
`DESCRIPTION
`Riopan Plus 2 is a double strength buffer antacid plus anti-
`gas combination product containing the unique chemical
`entity Magaldrate. Each teaspoonful (5 mL) of suspension
`contains Magaldrate, 1080 mg and Simethicone, 40 mg. Each
`Chew Tablet contains Magaldrate, 1080 mg and Simethi-
`cone, 20 mg. Riopan Plus 2 is considered dietetically sodium-
`free [containing not more than 0.013 mEq, (0.3) mg sodium
`per teaspoonful or 0.021 mEq, (0.5 mg) sodium per tablet.]
`ACTIONS
`The active antacid ingredient in Riopan Plus 2, Magaldrate,
`demonstrates a rapid and uniform buffering action. The
`acid-neutralizing capacity of Double Strength Riopan Plus 2
`is 30 mEq per 5mL and 30.0 mEq per tablet. Riopan Plus 2
`does not produce acid rebound or alkalinization. Simethi-
`cone reduces the surface tension of gas bubbles so that the
`gas is more easily eliminated.
`
`Physicians'Desk Reference®
`
`Consult 1992 Supplements for revisions
`
`INDICATIONS
`RIOPAN PLUS 2 is indicated for the relief of heartburn,
`sour stomach and acid indigestion accompanied by the symp-
`toms of gas. For symptomatic relief of hyperacidity associ-
`ated with the diagnosis of peptic ulcer, gastritis, peptic
`esophagitis, gastric hyperacidity, hiatal hernia, and postop-
`erative gas pain.
`DOSAGE AND ADMINISTRATION
`RIOPAN PLUS 2 (magaldrate and simethicone) Antacid
`plus Anti-Gas Suspension—Take one or two teaspoonfuls
`between meals and at bedtime, or as directed by the
`physician.
`RIOPAN PLUS 2 Antacid plus Anti-Gas Chew Tablets —
`Chew one or two tablets, between meals and at bedtime, or as
`directed by physician.
`WARNINGS
`Patients should not take more than 12 teaspoonfuls (or 25
`tablets) in a 24-hour period nor use the maximum dosage for
`more than two weeks, nor use if they have kidney disease,
`except under the advice and supervision of a physician.
`DRUG INTERACTION PRECAUTION
`Do not use in patients presently taking a prescription antibi-
`otic drug containing any form of tetracycline.
`INACTIVE INGREDIENTS
`Chew Tablets: Flavor, Magnesium Stearate, Methylcellu-
`lose, Polyethylene Glycol, Saccharin, Silica, Sorbitol, Starch,
`Sucrose, Titanium Dioxide. Suspension: Flavor, Glycerin,
`PEG-8 Stearate, Potassium Citrate, Saccharin, Sorbitan
`Stearate, Sorbitol, Xanthan Gum, Water.
`HOW SUPPLIED
`RIOPAN PLUS 2 Suspension —in 12 fl oz (355 mL) plastic
`bottles and 6 fl oz (176 mL) plastic bottles. Available in mint
`and cherry vanilla flavors.
`Store at room temperature (approximately 25'C). Avoid
`freezing.
`RIOPAN PLUS 2 Chew Tablets—in bottles of 60. Available
`in mint and cherry vanilla flavors.
`Shown in Product Identification Section, page 435
`
`SEMICID® OTC
`[sfin '£-8 id ]
`Vaginal Contraceptive Inserts
`
`DESCRIPTION
`Semicid is a safe and effective, non-systemic, reversible
`method of birth control. Each vaginal contraceptive insert
`contains 100 mg of the spermicide nonoxynol-9. It contains
`no hormones and is odorless and non-messy.
`When used consistently and according to directions, the ef-
`fectiveness of Semicid is approximately equal to vaginal
`foam contraceptives, but less than the pill or diaphragm.
`Semicid requires no applicator and has no unpleasant taste.
`Unlike foams, creams and jellies, Semicid does not drip or
`run, and Semicid inserts are easier to use than the dia-
`phragm. Also, Semicid does not effervesce like some inserts,
`so it is not as likely to cause a burning feeling.
`ACTIONS
`Semicid dissolves in the vagina and blends with natural vagi-
`nal secretions to provide double birth control protection: an
`effective sperm killing barrier plus a physical barrier that
`covers the cervical opening and adjoining vaginal walla
`INDICATION
`For the prevention of pregnancy.
`WARNINGS
`Do not insert in urethra. Do not take orally. If irritation
`occurs, discontinue use. If irritation persists, consult a
`physician. Keep this and all contraceptives out of the reach
`of children.
`PRECAUTIONS
`As with all spermicides, some Semicid users may experience
`irritation in using the product, but most women can use
`Semicid safely and without irritation.
`If douching is desired, one should wait at least six hours after
`intercourse before douching. If either partner experiences
`irritation, discontinue use. If irritation persists, consult a
`physician.
`If a menstrual period is missed, a physician should be
`consulted.
`DOSAGE AND ADMINISTRATION
`To use, unwrap one insert and insert it deeply into the va-
`gina. It is essential that Semicid be inserted at least 15 min-
`utes before intercourse. However, Semicid is also effective
`when inserted up to 1 hour before intercourse. If intercourse
`is delayed for more than 1 hour after Semicid is inserted, or if
`intercourse is repeated, then another insert must be in-
`serted. Semicid can be used as frequently as needed.
`
`INACTIVE INGREDIENTS
`Benzethonium Chloride, Citric Acid, D&C Red #21 Lake,
`D&C Red #33 Lake, Methylparaben, Polyethylene Glycol,
`"Water.
`HOW SUPPLIED
`Individually-wrapped inserts in Strip packaging of 10’s and
`20’s.
`Store at room temperature (not over 86°F or 30°C).
`Shown in Product Identification Section, page 435
`
`TODAY® OTC
`[tii-dd]
`Vaginal Contraceptive Sponge
`
`DESCRIPTION
`Today Vaginal Contraceptive Sponge is a soft polyurethane
`foam sponge containing nonoxynol-9, a spermicide used by
`millions of women for over 25 years.
`Today Sponge is Effective, Safe, and Convenient. Today
`Sponge provides 24-hour contraceptive protection without
`hormones, allowing spontaneity. Today Sponge is easy to
`use, non-messy, and disposable.
`ACTIVE INGREDIENT
`Each Today Sponge contains nonoxynol-9, one gram.
`INACTIVE INGREDIENTS
`Benzoic acid, citric acid, sodium dihydrogen citrate, sodium
`metabisulfite, Borbic acid, water in a polyurethane foam
`sponge.
`INDICATION
`For the prevention of pregnancy.
`ACTIONS
`Used as directed, Today Vaginal Contraceptive Sponge pre-
`vents pregnancy in three ways: 1) the spermicide nonoxynol-
`9 kills sperm before they can reach the egg; 2) Today Sponge
`traps and absorbs sperm; 3) Today Sponge blocks the cervix
`so that sperm cannot enter.
`Today Sponge is designed for easy insertion into the vagina.
`It is positioned against the cervix, and while in place pro-
`vides protection against pregnancy for 24 hours. The soft
`polyurethane foam sponge is formulated to feel like normal
`vaginal tissue and has a specially-designed ribbon loop at-
`tached to an interior web for maximum strength.
`In clinical trials of Today Sponge in over 1,800 women world-
`wide who completed over 12,000 cycles of use, the method-
`effectiveness, i.e., the level of effectiveness seen in women
`who followed the printed instructions exactly and who used
`Today Sponge every time that they had intercourse, was 89
`to 91%.
`INSTRUCTIONS
`Remove one Today Sponge from airtight inner pack, wet
`thoroughly with clean tap water, and squeeze gently several
`times until it becomes very sudsy. The water activates the
`spermicide. Fold the sides of Today Sponge upward until it
`looks long and narrow and then insert it deeply into the va-
`gina with the string loop dangling below. Protection begins
`immediately and continues for 24 hours. It is not necessary
`to add creams, jellies, foamB, or any other additional spermi-
`cide as long as Today Sponge is in place, no matter how many
`acts of intercourse may occur during a 24-hour period. Al-
`ways wait 6 hours after your last act of intercourse before
`removing Today Sponge. If you have intercourse when Today
`Sponge has been in place for 24 hours, it must be left in place
`an additional 6 hours after intercourse before removing it.
`To remove-Today Sponge, place a finger in the vagina and
`reach up and back to find the string loop. Hook a finger
`around the loop. Slowly and gently pull the Sponge out.
`Some women, especially first-time users, may have difficulty
`removing the Sponge. This situation may be due to tension or
`unusually strong muscular pressure. Simple relaxation of
`the vaginal muscles and bearing down should make it possi-
`ble to remove the Sponge without difficulty. See User In-
`struction Booklet (Section 7) for details on removing Today
`Sponge or call the Today TalkLine 1-800-223-2329.
`WARNINGS
`Some cases of Toxic Shock Syndrome (TSS) have been re-
`ported in women using barrier contraceptives including To-
`day® Sponge. Although the occurrence of TSS is uncom-
`mon, some studies indicate that there is an increased risk of
`non-menstrual TSS with the use of barrier contraceptives,
`including Today Sponge. Today Sponge should not be left in
`place for more than 30 hours after insertion. If you experi-
`ence two or more of the warning signs of TSS including fever,
`vomiting, diarrhea, muscular pain, dizziness, and rash simi-
`lar to sunburn, consult your physician or clinic immediately.
`If you have difficulty removing the sponge from your vagina
`or you remove only a portion of the sponge, contact the To-
`day Talk Line or consult your physician or clinic immedi-
`ately. Today Sponge should not be used during the menstrual
`period. After childbirth, miscarriage or other termination of
`pregnancy, it is important to consult your physician or clinic
`
`NOVARTIS EXHIBIT 2100
`Par v Novartis, IPR 2016-00084
`Page 3 of 4
`
`

`
`before using this product. If you have ever had Toxic Shock
`Syndrome do not use Today Sponge.
`A small number of men and women may be sensitive to the
`spermicide in this product (nonoxynol-9) and should not use
`this product if irritation occurs and persists. If you or your
`partner have ever experienced an allergic reaction to the
`spermicide used in this product, it is best to consult a physi-
`cian before using Today Vaginal Contraceptive Sponge. If
`either you or your partner develops burning or itching in the
`genital area, stop using this product and contact your physi-
`cian.
`A higher degree of protection against pregnancy will be af-
`forded by using another method of contraception in addition
`to a spermicidal contraceptive. This is especially true during
`the first few months, until you become familiar with the
`method. In our clinical studies, approximately one-half of all
`accidental pregnancies occurred during the first three
`months of use. Where avoidance of pregnancy is essential,
`the choice of contraceptive should be made in consultation
`with a doctor or a family planning clinic Any delay in your
`menstrual period may be an early sign of pregnancy. If this
`happens, consult your physician or clinic as soon as possible.
`In case of accidental ingestion of Today Sponge, call a poison
`control center, emergency medical facility or doctor (For
`most people ingestation of small quantities of spermicide
`alone should not be harmful.) As with any drug, if you are
`pregnant or nursing a baby, seek professional advice before
`using this product.
`HOW TO STORE
`Store at normal room temperature.
`HOW SUPPLIED
`Packages of 3s, 6s, and 12s.
`Shown in Product Identification Section, page 435
`
`EDUCATIONAL MATERIAL
`
`Books—Booklets—Brochures
`Today Sponge patient pamphlet available to physicians,
`pharmacists, and patients.
`Pictures—Charts
`8%X 11 laminated Instructions for Use chart available to
`physicians.
`Write to: TalkLine, Whitehall Laboratories, 685 Third Ave.,
`New York, NY 10017, or call toll-free 1-800-223-2329.
`
`Consult 1992 Supplements for revisions Physicians' Desk Reference®
`may result from renal insufficiency or renal tubular acidosis,
`where the administration of Sodium Citrate may be
`preferable.
`BICITRA is concentrated, and when administered after
`meals and before bedtime, maintains an alkaline pH without
`the need for a 2 A.M. dose. In the recommended dosage,
`BICITRA alkalinizes the urine without producing systemic
`alkalosis.-
`BICITRA is a fast-acting nonparticulate buffering agent and
`is useful for raising gastric pH. BICITRA has a rapid onset of
`action, and is decidedly advantageous over particulate alu-
`minum-magnesium containing antacids as a preanesthesia
`medication. BICITRA offers these advantages over Shohl’s
`Solution, while supplying equivalent alkalinizing effect and
`sodium content.
`BICITRA is pleasant tasting and highly tolerable, even when
`administered for long periods.
`CONTRAINDICATIONS
`Patients on sodium-restricted diets or with severe renal im-
`pairment. POLYCITRA-K or POLYCITRA-K CRYSTALS is
`recommended in those clinical situations where administra-
`tion of Potassium Citrate is preferred.
`PRECAUTIONS
`Should be used with caution by patients with low urinary
`output unless under the supervision of a physician. Patients
`with renal insufficiency should not ingest BICITRA concur-
`rently with aluminum-based antacids used as phosphate
`binders. Patients should be directed to dilute adequately
`with water and preferably to take each dose after meals to
`avoid saline laxative effect. Sodium salts should be used cau-
`tiously in patients with cardiac failure, hypertension, im-
`paired renal function, peripheral and pulmonary edema and
`toxemia of pregnancy. Periodic examinations of serum elec-
`trolytes, particularly serum bicarbonate level, should be
`carried out in those patients with renal disease in order to
`avoid these complications.
`ADVERSE REACTIONS
`BICITRA is generally well tolerated without any unpleasant
`side effects when given in recommended doses to patients
`with normal renal function and urinary output. However, as
`with any alkalinizing agent, caution must be used in certain
`patients with abnormal renal mechanisms to avoid develop-
`ment of alkalosis, especially in the presence of hypocalcemia.
`DOSAGE AND ADMINISTRATION
`BICITRA should be taken diluted in water followed by addi-
`tional water, if desired.
`For Systemic Alkalization: Usual Adult Prescribing Limits:
`Up to 150 mL daily. Occasional patients may require more or
`less to achieve the desired alkalinizing effect, and since
`1 mEq Sodium and 1 mEq Citrate is supplied per each mL,
`dosage is easy to regulate. To check urinary pH, HYDRION
`Paper (pH 6.0-8.0) or NITRAZINE Paper (pH 4.5-7.5) are
`available and easy to use.
`Usual Adult Dose: 10 to 30 mL, diluted in 1 to 3 ounces of
`water or juice, after meals and at bedtime.
`Usual Pediatric Dose: 5 to 10 mL diluted in 1 to 3 ounces of
`water or juice, after meals and at bedtime.
`As a Neutralizing Buffer 15 mL to 30 mL, taken as a single
`dose, or diluted, if desired, with 15 mL to 30 mL water, or as
`directed by physician.
`OVERDOSAGE
`Overdosage with sodium salts may cause diarrhea, nausea
`and vomiting, hypernoia, and convulsions.
`HOW SUPPLIED
`BICITRA—
`16 fl oz. (473 mL) (NDC 11414-207-01);
`4 fl oz (120 mL) (NDC 11414-207-04);
`1 gallon (3785 mL) (NDC 11414-207-08);
`15 mL UniLDose (NDC 11414-207-15);
`30 mL Unit-Dose (NDC 11414-207-30).
`
`Willen Drug Company
`18 NORTH HIGH STREET
`BALTIMORE, MD 21202
`
`BICITRA®—Sugar-Free 9
`[bye "si-trah ]
`(Sodium Citrate 8i Citric Acid
`Oral Solution USP)
`
`DESCRIPTION
`BICITRA is a pleasant tasting oral alkalinizing agent and a
`fast-acting nonparticulate antacid.
`BICITRA contains in each tablespoonful (15 mL)-
`SODIUM CITRATE Dihydrate 1500 mg (0.34 Molar)
`CITRIC ACID Monohydrate 1002 mg (0.32 Molar)
`Each mL contains 1 mEq Sodium ion and is equivalent to
`1 mEq Bicarbonate (HCO3).
`BICITRA is sugar free and nonalcoholic. BICITRA is the
`highly palatable, improved SHOHL’S Solution.
`CLINICAL PHARMACOLOGY
`Sodium Citrate is absorbed and metabolized to sodium bicar-
`bonate, thus acting as a systemic alkalizer. The effects are
`essentially those of chlorides before absorption and those of
`bicarbonates subsequently. Oxidation is virtually complete
`so that less than 5% of the citrate is excreted in the urine
`unchanged. BICITRA is a useful antacid for effectively buff-
`ering gastric acid, offering a maximum buffering capacity
`due to its equimolar ratio of Sodium Citrate to Citric Acid on
`a 1:1 basis.
`INDICATIONS AND ADVANTAGES
`BICITRA is useful for conditions requiring long-term main-
`tenance of an alkaline urine, as in patients where dissolution
`and control of uric acid and cystine calculi of the urinary
`tract is indicated, especially when the administration of po-
`tassium salts is undesirable or contraindicated. It is highly
`valuable in preventing uric acid nephropathy when adminis-
`tered to patients with hyperuricosuria due to underlying
`metabolic defects (e.g. gout), or who are receiving drugs (e.g.
`cancer chemotherapy or uricosuric agents), resulting in
`acute or chronic increases in urinary uric acid excretion.
`BICITRA is also effective for alleviating chronic metabolic
`acidosis, particularly when caused by conditions which
`
`NEUTRA-PHOS® Powder, Packets & Capsules OTC
`NEUTRA-PHOS®-K Powder. Packets & Capsules OTC
`[new "tra/i foss T
`Oral Phosphorus Dietary Supplement
`
`NEUTRA-PHOS and NEUTRA-PHOS-K supply the physio-
`logically important element—PHOSPHORUS—as inorganic
`orthophosphate, in a well tolerated oral compound. Each
`contains a chemically balanced combination of readily solu-
`ble inorganic phosphates, affording a very high source of
`elemental Phosphorus. Both products supply equal concen-
`tration of elemental Phosphorus.
`NEUTRA-PHOS is a stable powder combination of mono-
`basic and dibasic Sodium and Potassium Phosphates.
`NEUTRA-PHOS-K is a stable sodium-free powder combina-
`tion of monobasic and dibasic Potassium Phosphates in-
`tended for oral use in low sodium diets.
`Both products form an oral solution by reconstitution with
`water and are neutral (pH 7.3), isotonic, pleasant tasting
`sources of Phosphorus. There is less than 1 calorie per aver-
`age dose.
`
`2423
`
`INDICATIONS
`NEUTRA-PHOS and NEUTRA-PHOS-K are recommended
`as oral Phosphorus supplements, particularly if the diet
`supplies an insufficient quantity of Phosphorus, or if meta-
`bolic requirements for Phosphorus are increased. In addi-
`tion, NEUTRA-PHOS and NEUTRA-PHOS-K are useful in
`the treatment of children and adults with conditions associ-
`ated with excessive renal phosphate loss or inadequate gas-
`trointestinal absorption of phosphate. They are also useful
`as an adjunct supplement in the management of phosphate
`diabetes.
`ADVANTAGES
`NEUTRA-PHOS and NEUTRA-PHOS-K, reconstituted to
`an oral liquid, provide a chemically balanced supply of Phos-
`phorus in a pH neutral solution that shows rapid absorption
`and utilization from the alimentary tract. These liquid prod-
`ucts have the advantage over coated or uncoated tablets, as
`slowly dissolving tablets may cause local gastrointestinal
`irritation or inflammation in sensitive individuals. Both
`products are highly concentrated and thus economically
`provide inorganic Phosphate. They are especially useful for
`long term maintenance of an adequate daily supply of Phos-
`phorus. NEUTRA-PHOS supplies Sodium and Potassium in
`equimolar proportions—a decided advantage over products
`which supply a high amount of sodium and a low amount of
`potassium per dose. NEUTRA-PHOS-K supplies only Potas-
`sium and is recommended when a low sodium intake is indi-
`cated.
`ELECTROLYTES SUPPLIED
`75 mL of the reconstituted solution or contents of 1 packet or
`1 capsule supplies:
`NEUTRA-PHOS
`Electrolyte mg mEq mg/
`mL
`
`Phosphorus
`Phosphate (P04)
`Sodium
`Potassium
`NEUTRA-PHOS-K
`Electrolyte
`
`250
`765
`164
`278
`
`mg
`
`14.25
`
`7.125
`7.125
`
`mEq
`
`3.33
`10.20
`2.18
`3.70
`
`mg/
`mL
`
`Phosphorus 250 14.25 3.33
`Phosphate (PO«) 765 - 10.20
`Sodium none none none
`Potassium 556 14.25 7.41
`
`OSMOLALITY
`NEUTRA-PHOS Solution’: 223-236 milliosmols per kg
`(mOsm/kg)
`NEUTRA-PHOS-K Solution’: 240-244 milliosmols per kg
`(mOsm/kg)
`(’reconstituted in water as per label directions. Refer to
`Packets and Capsules description.)
`AVERAGE DIRECTIONS FOR ADULTS AND
`CHILDREN
`4 or more years of age: 75 mL of the oral solution, or contents
`of 1 packet or capsule, equivalent to 250 mg Phosphorus,
`taken 4 times a day. (See Packets and Capsules description.)
`PEDIATRIC DOSE
`Infants and children under 4 years of age: 60 mL of the oral
`solution, equivalent to 200 mg of Phosphorus, taken 4 times a
`day.
`USUAL DOSE RANGE
`75 mL to 600 mL of the oral solution, or contents of 1 to 8
`packets or capsules (equivalent from 250 mg to 2 grams of
`Phosphorus) taken daily in divided doses, after meals and at
`bedtime.*
`75 mL of the reconstituted solution, 1 packet, or 1 capsule, 4
`times a day, supplies 1 g Phosphorus. 150 mL of the recon-
`stituted solution, 2 packets, or 2 capsules, 3 times a day,
`supplies 1.5 g Phosphorus. Phosphorus. (See Packets and
`Capsules description).*
`PRECAUTIONS AND SIDE EFFECTS
`Reconstitute powder and contents of packets and capsules as
`directed before taking. Occasionally some individuals may
`experience a mild laxative effect for the first day or two
`when beginning to use NEUTRA-PHOS. If this persists to an
`unpleasant degree, reduce the daily intake until this effect
`subsides or, if necessary, discontinue its use. NEUTRA-
`PHOS-K contains FD&C Yellow #6.
`(’This U.S. R.D.A. for Phosphorus is 0.8 g for children 1 to 10
`years; 0.8 g for adults 25 years or older; and 1.2 g for ages 11
`to 24, pregnant, or lactating women.)
`
`Continued on next page
`
`NOVARTIS EXHIBIT 2100
`Par v Novartis, IPR 2016-00084
`Page 4 of 4