Label: ACETAMINOPHEN tablet, extended release
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NDC Code(s):
71335-1340-1,
71335-1340-2,
71335-1340-3,
71335-1340-4, view more71335-1340-5
- Packager: Bryant Ranch Prepack
- This is a repackaged label.
- Source NDC Code(s): 57896-268
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated July 7, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- 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 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
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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 OR COMMENTS ?
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HOW SUPPLIED
Product: 71335-1340
NDC: 71335-1340-1 30 TABLET, EXTENDED RELEASE in a BOTTLE
NDC: 71335-1340-2 100 TABLET, EXTENDED RELEASE in a BOTTLE
NDC: 71335-1340-3 50 TABLET, EXTENDED RELEASE in a BOTTLE
NDC: 71335-1340-4 60 TABLET, EXTENDED RELEASE in a BOTTLE
NDC: 71335-1340-5 120 TABLET, EXTENDED RELEASE in a BOTTLE
- Acetaminophen ER 650mg Tablet
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN
acetaminophen tablet, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71335-1340(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) MICROCRYSTALLINE CELLULOSE (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:71335-1340-1 30 in 1 BOTTLE; Type 0: Not a Combination Product 07/01/2019 2 NDC:71335-1340-2 100 in 1 BOTTLE; Type 0: Not a Combination Product 07/01/2019 3 NDC:71335-1340-3 50 in 1 BOTTLE; Type 0: Not a Combination Product 07/01/2019 4 NDC:71335-1340-4 60 in 1 BOTTLE; Type 0: Not a Combination Product 07/01/2019 5 NDC:71335-1340-5 120 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 - Bryant Ranch Prepack (171714327) Establishment Name Address ID/FEI Business Operations Bryant Ranch Prepack 171714327 REPACK(71335-1340) , RELABEL(71335-1340)