Label: PREMIER VALUE ARTHRITIS PAIN RELIEVER- acetaminophen tablet, extended release
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Contains inactivated NDC Code(s)
NDC Code(s): 68016-340-08, 68016-340-40 - Packager: Chain Drug Consortium, LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated October 5, 2015
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT (IN EACH GELTAB)
- PURPOSE
- USES
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WARNINGS
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
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- more than 6 geltabs in 24 hours, which is the maximum daily amount
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- with other drugs containing acetaminophen
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- 3 or more alcoholic drinks every day while using this product
Do not use
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- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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- if you have difficulty swallowing large tablets or capsules. People over 65 may have difficulty swallowing these tablets.
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- if you are allergic to acetaminophen or any of the inactive ingredients in this product.
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DIRECTIONS
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- do not take more than directed (see overdose warning)
adults
▪ take 2 geltabs every 8 hours. Swallow only one geltab at a time.
▪ take a sip of water before swallowing each geltab and wash each geltab down with water (up to a full 8 oz. glass).
▪ swallow whole - do not crush, chew, split or dissolve
▪ do not take more than 6 geltabs in 24 hours
▪ do not use for more than 10 days unless directed by a doctorunder 18 years of age
▪ ask a doctor
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
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PRINCIPAL DISPLAY PANEL
Premier Value®
NDC 68016-340-08
Use only as directed.
See New Warnings Information
EASY TO OPEN BOTTLE
Lasts up to 8 hours
Arthritis Pain Relief
Acetaminophen Extended-Release Tablets, USP 650 mg
Pain Reliever/Fever Reducer
For the Temporary Relief of Minor Arthritis Pain
THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN
DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN
80 GELTABS* 650 mg EACH
(*Gelatin-Coated Tablets)
COMPARE TO THE ACTIVE INGREDIENT OF TYLENOL®ARTHRITIS PAIN†
DISTRIBUTED BY CHAIN DRUG CONSORTIUM
5095711/0512
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INGREDIENTS AND APPEARANCE
PREMIER VALUE ARTHRITIS PAIN RELIEVER
acetaminophen tablet, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-340 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) HYPROMELLOSES (UNII: 3NXW29V3WO) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) STARCH, CORN (UNII: O8232NY3SJ) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POVIDONES (UNII: FZ989GH94E) Product Characteristics Color white (White to Yellow) Score no score Shape ROUND Size 13mm Flavor Imprint Code 350 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68016-340-08 80 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:68016-340-40 40 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078569 12/21/2012 Labeler - Chain Drug Consortium, LLC (101668460) Registrant - Ranbaxy Pharmaceuticals Inc. (937890044) Establishment Name Address ID/FEI Business Operations Ohm Laboratories Limited 184769029 MANUFACTURE(68016-340)