Label: ACETAMINOPHEN tablet, film coated, extended release
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Contains inactivated NDC Code(s)
NDC Code(s): 50594-183-24 - Packager: BIG LOTS STORES, INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated December 30, 2020
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
- Liver warning
- Allergy alert
- 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 a doctor if
- If pregnant or breast-feeding
- Keep out of reach of children
- Overdose warning
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Directions
■ d o 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?
- Acetaminophen Extended Release Tablets 650 mg, 24ct
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN
acetaminophen tablet, film coated, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50594-183 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 (4000 MPA.S AT 1%) (UNII: ZYD53NBL45) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) POVIDONE K30 (UNII: U725QWY32X) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) Product Characteristics Color white (White to off white colored) Score no score Shape OVAL (Capsule shaped, biconvex intact film coated tablets) Size 19mm Flavor Imprint Code G;650 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50594-183-24 24 in 1 BOTTLE; Type 0: Not a Combination Product 03/31/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA211544 03/31/2020 Labeler - BIG LOTS STORES, INC. (017885351)