Label: ACETAMINOPHEN tablet, film coated, extended release
- NDC Code(s): 63868-089-01, 63868-089-50
- Packager: Chain Drug Marketing Association Inc.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated December 30, 2019
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- 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
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
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
- 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 doctor
under 18 years of age - ask a doctor
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
-
PRINCIPAL DISPLAY PANEL - 100 Caplet Bottle Carton
QC®
QUALITY
CHOICENDC 63868-089-01
†Compare to
Active Ingredient in
TYLENOL® Arthritis PainLast up to 8 Hours | Use Only as Directed
Arthritis Pain Relief
Acetaminophen Extended-release Tablets USP, 650 mg
Pain Reliever | Fever Reducer
For the Temporary Relief of Minor Arthritis Pain
DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN
THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN
100 CAPLETS*
(*capsule-shaped tablets)EASY TO OPEN BOTTLE
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN
acetaminophen tablet, film coated, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-089 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) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) STARCH, 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:63868-089-50 50 in 1 BOTTLE; Type 0: Not a Combination Product 04/30/2002 2 NDC:63868-089-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 04/30/2002 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076200 04/30/2002 Labeler - Chain Drug Marketing Association Inc. (011920774) Registrant - Sun Pharmaceutical Industries Inc. (146974886) Establishment Name Address ID/FEI Business Operations Ohm Laboratories Inc. 184769029 manufacture(63868-089)