Label: ACETAMINOPHEN tablet, film coated, extended release
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Contains inactivated NDC Code(s)
NDC Code(s): 41520-333-01 - Packager: American Sales Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 17, 2013
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT (IN EACH CAPLET)
- PURPOSE
- USES
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WARNINGS
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 6 caplets in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Do not use
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- 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 caplets every 8 hours with water
▪ swallow whole - do not crush, chew, split or dissolve
▪ do not take more than 6 caplets in 24 hours
▪ do not use for more than 10 days unless directed by a doctorunder 18 years of age ▪ ask a doctor
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do not take more than directed (see overdose warning)
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN
acetaminophen tablet, film coated, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41520-333 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) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE (UNII: FZ989GH94E) STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM LAURYL SULFATE (UNII: 368GB5141J) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white Score no score Shape OVAL (Capsule Shaped) Size 19mm Flavor Imprint Code cor116 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41520-333-01 100 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076200 04/30/2002 Labeler - American Sales Company (809183973) Registrant - Ranbaxy Pharmaceuticals Inc. (937890044) Establishment Name Address ID/FEI Business Operations Ohm Laboratories Inc. 184769029 manufacture(41520-333)