0001
`
`PSG2014
`Catalent Pharma Solutions v. Patheon Softgels
`IPR2018-00422
`
`

`

`1910/F’HYSICIANS’ DESK REFERENCE®
`______________________________________.___________———————————
`CHILDREN'S VICKS® 'NYQUIL®
`O
`ACTIVE INGREDIENT
`Cold/Cough Relief
`-
`Pratt—Cont.
`Antihistamine/Nasal Decongestant/Cough Suppressant
`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-I-4215.
`‘
`INDICATIONS
`For the temporary relief of minor aches and pains associated
`with the common cold, headache, toothache, muscular aches,
`backache, for the minor pain of arthritis, 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
`symptoms persist. 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 not give this product to 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
`' more 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 under a 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 AIDOCTOR 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 of accidental 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 orxoval-shaped caplets debossed
`with “ALEVE”. Child-resistant “Safety SquEASE” bottles of
`24, 50, and 100 tablets or caplets, with fold-out back label
`on the 24 and 50 count bottles containing important
`information.
`STORAGE
`Store at room temperature (typically 59—8513“ or 15—30°C).
`Avoid excessive heat (104T or 40°C).
`
`
`to higher doses. Since steady‘state plasma levels are
`achieved on the second day of dosing, if symptoms so were
`rant, titration may proceed more rapidly provided the pa—
`tient is assessed frequently. Titration to doses above 120 mg
`is not recommended.
`Angina patients 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
`t.i.d. of Procardia capsules may be changed to 90 mg once
`daily of PROCARDIA XL Extended Release Tablets). Subse~
`quent titration to higher or lower doses may be necessary
`and should be initiated as clinically warranted. Experience
`with doses greater than 90 mg in patients with angina is lim-
`ited. Therefore, doses greater than 90 mg should be used with
`caution and only when clinically warranted.
`No “rebound effect” has been observed upon discontinuation
`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.
`(to-Administration with Other Antianginal Drugs
`Sublingual nitroglycerin 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 round biconvex, rose-pink, film-
`coated tablets in:
`.
`Bottles of 100:
`30 mg (NDC 59012-26566) (NDC 0069-2650-66)
`60 mg (NDC 59012-26666) (NDC 0069-2660663)
`90 mg (NDC 59012—267—66) (NDC 0069-2670-66)
`Bottles of 300:
`30 mg (NDC 59012-265-72) (NDC 0069—2653072)
`60 mg (NDC 59012266572) (NDC 0069266072)
`Bottles of 5000:
`30 mg (NDC 59012—26594) (NDC 0069265094)
`60 mg (NDC 59012-26694) (NDC 0069-2660-94)
`Unit dose packages of 100:
`30 mg (NDC 59012-26541) (NDC 0069-2650411)
`60 mg (NDC 59012-26641) (NDC 0069-2660413
`90 mg (NDC 59012-26741)
`Store below 86°F (30°C).
`Protect from moisture and humidity.
`© 1992 PFIZER INC
`Pfizer Pratt
`Pharmaceuticals
`Division of Pfizer Inc, NY, NY 10017
`774848009
`Revised September 1993
`Shown in Product Identification Guide, page 3%
`
`ZOLOFT®
`(sertraline hydrochloride)
`Tablets
`
`R
`
`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 I]
`Naproxen Sodium Tablets, USP
`Pain Reliever/Fever Reducer
`
`OTC
`
`ALLERGY WARNING
`Do not take this product if you have had either hives or a
`severe allergic reaction after taking any pain reliever. Even
`though this product may not contain the same ingredient,
`ALEVE could 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.
`
`
`
`Information will be superseded by supplements and subsequent editions
`
`0002
`
`
`
`CHILDREN'S
`VICKS® CHLORASEPTICG)
`SORE THROAT LOZENGES
`Benzocaine/Oral Anesthetic
`
`(See PDR For Nonprescription Drugs.)
`
`OTC
`
`CHILDREN'S VICKS® CHLORASEPTICG‘)
`SORE THROAT SPRAY
`Phenol/Oral
`Anesthetic/Antiseptic
`
`OTC
`
`(See PDR For Nonprescription Drugs.)
`
`CHILDREN'S VICKS® DAvouIL®
`Allergy Relief
`Nasal Decongestant/Antihistamine -
`
`orc
`
`(See PDR For Nonprescription Drugs.)
`
`(See PDR For Nonprescription Drugs.)
`
`HEAD 81 SHOULDERS®
`DANDRUFF SHAMPOO
`
`(See PDR For Nonprescription Drugs.)
`
`HEAD 81. SHOULDERS® DRY SCALP
`DANDHUFF SHAMPOO
`
`(See PDR For Nonprescription Drugs.)
`
`0'
`
`O‘
`
`HEAD & SHOULDERS®
`INTENSIVE TREATMENT DANDRUFF AND
`SEBORRHEIC DERMATITIS SHAMPOO
`
`O
`
`(See PDR For Nonprescription Drugs.)
`
`METAMUCIL®
`[met uh-mu sil]
`(psyllium hydrophilic mucilloid)
`
`0'
`
`‘
`
`DESCRIPTION
`Metamucil contains a bulk forming natural therapeutiI
`her for restoring and maintaining regularity as rec
`mended by a physician. It contains psyllium hydropl
`mucilloid, a highly efficient fiber derived from the husl
`the psyllium seed (Plantago ovata). Metamucil contain:
`chemical stimulants and does not disrupt normal bowel f1
`tion. Each dose contains approximately 3.4 grams of p
`lium hydrophilic mucilloid. Inactive ingredients, sodi
`potassium, calories, carbohydrate, fat and phenylaléu
`content are shown in Table 1 for all forms andflavors.
`traSweet® ‘ brand sweetener (aspartame) is used in flaw
`sugar—free Metamucil powdered products. Phenylketonu
`should be aware that phenylalanine is present in Metam
`products that contain Nutrasweet®. Metamucil Sugar—I
`Regular Flavor contains no sugar and no artifi
`sweetners.
`,
`_
`Metamucil in powdered forms is gluten-free. Wafers con‘
`gluten: Apple Crisp contains 0.7g/dose, Cinnamon S
`contains 0.5g/dose.
`ACTIONS
`The active ingredient in Metamucil is psyllium, a net
`fiber which promotes elimination due to its bulking effet
`the colon. This bulking effect is due to both the water-hob
`capacity of undigested fiber and the increased bacterial :3
`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
`Metamucil is indicated in the management of chronic co:
`pation, in irritable bowel syndrome, as adjunctive there}
`the constipation of diverticular disease, in the bowel r
`agement of patients with hemorrhoids, and for constipa
`associated with convalescence and senility and for occasi
`constipation during pregnancy when under the care
`physician. Pregnancy: Category B.
`CONTRAINDICATIONS
`Intestinal obstruction, fecal impaction.’
`Known allergy to any component.
`WARNINGS
`Patients are advised they should not use the product wit"
`consulting a doctor when abdominal pain, nausea, or vc
`ing are present or if they have noticed a sudden Chang
`bowel habits that persists over a period of 2 weeks, or n
`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 C
`TIONED THAT TAKING THIS PRODUCT WITHOUT I
`QUATE FLUID MAY CAUSE IT TO SWELL AND ELI
`THE THROAT 0R ESOPHAGUS AND MAY CAUSE CI
`ING. THEY SHOULD NOT TAKE THE PRODUCT IF T
`HAVE DIFFICULTY IN SWALLOWING.
`IF, THEY
`PERIENCE CHEST PAIN, VOMITII‘IGl OR DIFFICULT'
`SWALLOWING OR BREATHING AFTER TAKING 7
`PRODUCT. THEY ARE ADVISED TO SEEK IMMEDI
`MEDICAL ATTENTION. Psyllium products may cause 2
`gic reaction in people sensitive to inhaled or ingested
`lium. Keep. this and all medications out of the reac
`children.
`
`0002
`
`