`
`PSG2014
`Catalent Pharma Solutions v. Patheon Softgels
`IPR2018-00422
`
`
`
`Each. [tablet] [caplet] contains naproxen sodium 220 mg
`(naproxen 200 mg and sodium 20 mg).
`INACTIVE INGREDIENTS
`Magnesium Stearate, Microcrystalline Cellulose, Povidone,
`Talc, Opadry YS-1-4215.
`.
`INDICATIONS
`For the temporaryrelief of minor aches and pains associated
`with the commoncold, headache,toothache, muscular aches,
`backache,for the minorpain ofarthritis, for the pain of men-
`strual cramps and for the reduction of fever.
`DOSAGE AND ADMINISTRATION
`Adults: Take one [tablet] [caplet] every 8 to.12 hours while
`symptomspersist. With experience, some people may find
`that an initial dose of two[tablets] [caplets] followedby one
`{tablet} [caplet] 12 hours later,if necessary, will give better
`relief, Do not exceed three [tablets] [caplets] in 24 hours unless
`directed to do so by a doctor. The smallest effective dose
`should be used. A full glass of water or other liquid is recom-
`mended with each dose.
`:
`Adults over age 65: Do not take more than one [tablet]
`[caplet] every 12 hours, unless directed to do so by a
`doctor.
`Children under-age 12: Do notgive this productto children
`under 12, except under the advice and supervision of a
`doctor,
`GENERAL WARNINGS
`Do not take ALEVE for more than 10 days for pain, or for
`more than 3 days for fever, unless directed by a doctor.
`Consult a doctor if:
`*your pain or fever persists or gets worse
`*the painful area is red or swollen
`*you take any other drugs on a regular basis
`*you have had serious side effects from any pain reliever
`*you have any new or unusual symptoms
`*Inore than mild heartburn, upset stomach, or stomach pain
`occurs with use of this product or if even mild symptoms
`persist
`Although naproxen sodium is indicated for the same condi-
`tions as aspirin, ibuprofen and acetaminophen, it should not
`be taken with them or other naproxen-containing products
`except undera doctor’s direction. As with any drug,.if you
`are pregnant or nursing a baby, seek the advice of a health
`professional before using this product. IT IS ESPECIALLY
`IMPORTANT NOT TO USE NAPROXEN SODIUM DUR-
`ING THE LAST 3 MONTHS OF PREGNANCY UNLESS
`SPECIFICALLY DIRECTED TO DO SO BY A DOCTOR BE-
`CAUSE IT MAY CAUSE PROBLEMS IN THE UNBORN
`CHILD OR COMPLICATIONS DURING DELIVERY.
`KEEP THIS AND ALL DRUGS OUT OF THE REACH OF
`CHILDREN.In case ofaccidental overdose, seek professional
`assistance or contact a poison control center immediately.
`If you have questions, comments or problems,call 1-800-395-
`0689 to report them.
`:
`HOW SUPPLIED
`Light blue round tablets oroval-shaped caplets debossed
`with “ALEVE”. Child-resistant “Safety SquEASE” bottles of
`$4, 50, and 100 tablets or eaplets, with fold-out back label
`on the 24 and 50 count bottles containing important
`information.
`:
`STORAGE
`Store at room temperature (typically 59-B5I° or 15-30°C).
`Avoid excessive heat (104°F or 40°C).
`
`
`(See PDR For Nonprescription Drugs.)
`
`HEAD & SHOULDERS®
`DANDRUFF SHAMPOO
`
`(See PDR For Nonprescription Drugs.)
`
`HEAD & SHOULDERS® DRY SCALP
`DANDRUFF SHAMPOO
`
`(See PDR For Nonprescription Drugs.)
`
`.
`HEAD & SHOULDERS®
`INTENSIVE TREATMENT DANDRUFF AND
`SEBORRHEIC DERMATITIS SHAMPOO
`
`(See PDR For Nonprescription Drugs.)
`
`METAMUCIL®
`[met uh-mu sil]
`(psyltium hydrophilic mucilloid)
`
`:
`
`0
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`Oo
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`c
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`
` CHILDREN’S VICKS® NYQUIL®
`
`orc
`
`oTc
`
` ACTIVE INGREDIENT
`
`to higher doses. Since steady-state plasma levels are
`achieved on the second day of dosing, if symptoms so war-
`rant, titration may proceed morerapidly provided the pa-
`tient is assessed frequently. Titration to doses above 120 mg
`is not recommended.
`Anginapatients controlled on Procardia capsules alone or in
`combination with other antianginal medications may be
`safely switched to PROCARDIA XL Extended Release Tab-
`lets at the nearest equivalent total daily dose (e-g., 30 mg
`tid. of Procardia capsules may be changed to 90 mg once
`daily of PROCARDIA XL Extended Release Tablets). Subse-
`quent titration toe higher or lower doses may be necessary
`and should be initiated as clinically warranted. Experience
`with doses greater than 90 mg in patients with anginais lim-
`ited. Therefore, doses greater than 90 mg should be used with
`caution and only whenclinically warranted.
`No “reboundeffect” has been observed upondiscontinuation
`of PROCARDIA XL Extended Release Tablets. However,if
`discontinuation of nifedipine is necessary, sound clinical
`practice suggests that the dosage should be decreased gradu-
`ally with close physician supervision,
`Care should be taken when dispensing PROCARDIA XL to
`assure that the extended release dosage form has been
`prescribed.
`Co-Administration with Other Antianginal Drugs
`Sublingualnitroglycerin may be taken as required for the
`control of acute manifestations of angina, particularly dur-
`ing nifedipine titration. See PRECAUTIONS, Drug Interac-
`tions, for information on co-administration of nifedipine
`with beta blockers or long acting nitrates.
`HOW SUPPLIED
`PROCARDIA XL® Extended Release Tablets are supplied
`as 30 mg, 60 mg and 90 mg roundbiconvex, rose-pink, film-
`coated tablets in:
`:
`Bottles of 100:
`30 mg (NDC 59012-265-66) (NDC 0069-2650-66)
`60 mg (NDC 59012-266-66) (NDC 0069-2660-66)
`90 mg (NDC 59012-267-66) (NDC 0069-2670-66)
`Bottles of 300:
`30 mg (NDC 59012-265-72) (NDC 0069-2650-72)
`60 mg (NDC 59012-266-72) (NDC 0069-2660-72)
`Bottles of 5000:
`30 mg (NDC 59012-265-94) (NDC 0069-2650-94)
`60 mg (NDC 59012-266-94) (NDC 0069-2660-94)
`Unit dose packages of 100:
`30 mg (NDC 59012-265-41) (NDC 0069-2650-41)
`60 mg (NDC 59012-266-41) (NDC 0069-2660-41)
`90 mg (NDC 59012-267-41)
`Store below 86°F (30°C).
`Protect from moisture and humidity.
`© 1992 PFIZER INC
`Pfizer Pratt
`Pharmaceuticals
`Division of Pfizer Inc, NY, NY 10017
`7T-4848-00-9
`Revised September 1993:
`Shown in Preduct Identification Guide, page 324
`
`
`ZOLOFT®
`(sertraline hydrochloride}
`Tablets
`
`B
`
`is co-promoted by the Roerig and Pratt
`This product
`Pharmaceuticals Divisions, Pfizer Inc.
`Please refer to Roerig Division, Pfizer Inc for complete
`prescribing information, pages 2109-2112
`Shown in Product Identification Section, page 327
`
`Procter & Gamble
`P.O. BOX 5516
`CINCINNATI OH 45201
`
`ALEVE®
`[a lév
`Naproxen Sodium Tablets, USP
`Pain Reliever/Fever Reducer
`
`ore
`
`ALLERGY WARNING
`Do not take this product if you have hadeither hives or a
`severeallergic reaction after taking any pain reliever. Even
`though this product may not contain the same ingredient,
`ALEVEcould cause similar reactions in patients allergic to
`other pain relieving drugs.
`.
`ALCOHOL WARNING
`If you generally consume 3 or more alcohol-containing
`drinks per day, you should consult your physician for advice
`on when and how you should take ALEVE and other pain
`relievers.
`
`4910/PHYSICIANS’ DESK REFERENCE®
`
`1910/PHYSICIANS”DESKREFEREe
`Oo
`Cold/CoughRelief
`2
`‘
`Pratt—Cont.
`Antihistamine/Nasal Decongestant/Cough Suppressant
`
`DESCRIPTION
`Metamucil contains a bulk forming natural therapeuti
`ber for restoring and maintaining regularity as rec
`mended by a physician. It.contains psyllium hydropt
`mucilloid, a highly efficient fiber derived from the hus!
`the psyllium seed (Plantago ovata). Metamucil contains
`chemical stimulants and does notdisrupt normalbowelft
`tion. Each dose. contains approximately 3.4 grams of 5
`lium hydrophilic mucilloid. Inactive ingredients, sodi
`potassium, calories, carbohydrate, fat and phenylalar
`content are shown in Table 1 for all forms and flavors.
`traSweet®* brand sweetener(aspartame)is used in flavc
`sugar-free Metamucil powdered products. Phenylketonu
`should be aware that phenylalanine is present in Metam
`products that-contain Nutrasweet®. Metamucil Sugar-t
`Regular Flavor contains no sugar and no artifi
`sweetners.
`.
`.
`Metamucil in powdered formsis gluten-free. Wafers con
`gluten: Apple Crisp contains 0.7g/dose, Cinnamon 8
`contains 0,5g/dose.
`ACTIONS
`The active ingredient in Metamucil is psyllium, a nat
`fiber which promotes elimination due to its bulkingeffex
`the colon. Thig bulking effect is due to both the water-holt
`capacity ofundigested fiber and the increased bacterial'n
`following partial fiber digestion, These. actions result in
`largement ofthe lumen ofthe colon, and'softer stool, the
`decreasing intraluminal pressure and straining, and sp
`ing colonic transit in constipated patients.
`-
`/
`INDICATIONS
`Metamucilis indicated in the management.of chronicco:
`pation,in irritable bowel syndrome,as adjunctive theraz
`the constipation of diverticular disease, in the bowel r
`agementof patients with hemorrhoids, and for constipa
`associated with convalescence andsenility andfor occasi
`constipation during pregnancy when under the care
`physician. Pregnancy: Category B.
`CONTRAINDICATIONS
`CHILDREN’S
`oTc
`Intestinal obstruction, fecal impaction.’
`alS
`VICKS® CHLORASEPTIC®
`SORE THROAT LOZENGES
`Known allergy to-any component.
`Benzocaine/Oral Anesthetic
`WARNINGS
`Patients are advised they should notuse the product wit
`consulting a doctor when abdominal pain, nausea, or vc
`ing are presentorif they have noticed a. sudden chang
`bowel habits that persists over a period of 2 weeks, or 1
`bleeding. Patients are advised to consult a physician if
`stipation persists for longer than. one week,,as this may
`sign of.a serious medical condition. PATIENTS ARE ¢
`TIONED THAT TAKING THIS PRODUCT. WITHOUT /
`QUATE FLUID MAY CAUSE IT TO.SWELL AND. BL
`THE THROAT OR ESOPHAGUS AND MAY. CAUSECI
`ING. THEY SHOULD NOT TAKE THE PRODUCTIF T
`HAVE DIFFICULTY IN SWALLOWING...
`IF: THEY.
`PERIENCE CHEST PAIN, VOMITING, OR DIFFICULT
`SWALLOWING OR BREATHING AFTER TAKING -
`PRODUCT, THEY ARE ADVISED TO SEEK IMMEDI
`MEDICAL ATTENTION.Psyllium products:may cause
`gic reaction in people sensitive to inhaled or ingested
`lium. Keep. this and all medications out of the. reac
`children.
`
`(See PDR For Nonprescription Drugs.)
`
`CHILDREN’S VICKS® CHLORASEPTIC®
`SORE THROAT SPRAY
`.
`Phenot/Oral
`Anesthetic/Antiseptic
`
`(See PDR For Nonprescription Drugs.)
`
`CHILDREN'S VICKS® DAYQUIL®
`Allergy Relief
`Nasal Decongestant/Antihistamine-
`
`(See PDR For Nonprescription Drugs.)
`
`Information will be superseded by supplements and subsequent editions
`
`0002
`
`0002
`
`