Label: ACETAMINOPHEN tablet, extended release
- NDC Code(s): 57896-268-01
- Packager: GERI-CARE PHARMACEUTICAL CORP
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated September 17, 2019
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT (IN EACH CAPLET)
- PURPOSE
- USES
-
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 everyday while using this productAllergy 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
- Ask a doctor before use if you have
- Ask a doctor or pharmacist before use if you are
- Stop use and ask doctor if
- If pregnant or breast-feeding
- Keep out of reach of children
-
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 OR COMMENTS ?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ACETAMINOPHEN
acetaminophen tablet, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57896-268 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 HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POVIDONE K30 (UNII: U725QWY32X) STARCH, CORN (UNII: O8232NY3SJ) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white Score no score Shape CAPSULE Size 19mm Flavor Imprint Code G650 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57896-268-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 07/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA211544 07/01/2019 Labeler - GERI-CARE PHARMACEUTICAL CORP (611196254) Registrant - GERI-CARE PHARMACEUTICAL CORP (611196254)