Label: ACETAMINOPHEN - APAP 8 HOUR- acetaminophen tablet, film coated, extended release
- NDC Code(s): 63941-336-50
- Packager: Valu Merchandisers Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated December 30, 2019
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- SPL UNCLASSIFIED SECTION
- Active ingredient (in each caplet)
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
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.
Stop use and ask a doctor if
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- new symptoms occur
- redness or swelling is present
These could be signs of a serious condition.
- do not take more than directed (see overdose warning)
adults and children 12 years and over
- 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
children under 12 years
- do not use
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL - 650 mg Caplet Bottle Carton
COMPARE TO THE ACTIVE INGREDIENT OF TYLENOL® 8 HOUR**
Last up to 8 Hours
Use Only as Directed.
Extended-release Tablets USP, 650 mg
Pain Reliever/Fever Reducer
For Up to 8 Hours Relief of Minor Muscle Aches & Pain
DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN
INGREDIENTS AND APPEARANCE
ACETAMINOPHEN - APAP 8 HOUR
acetaminophen tablet, film coated, extended release
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63941-336 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:63941-336-50 50 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 - Valu Merchandisers Company (868703513) Registrant - Sun Pharmaceutical Industries Inc. (146974886) Establishment Name Address ID/FEI Business Operations Ohm Laboratories Inc. 184769029 manufacture(63941-336)