Label: ACETAMINOPHEN tablet
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NDC Code(s):
71335-9644-0,
71335-9644-1,
71335-9644-2,
71335-9644-3, view more71335-9644-4, 71335-9644-5, 71335-9644-6, 71335-9644-7, 71335-9644-8, 71335-9644-9
- Packager: Bryant Ranch Prepack
- This is a repackaged label.
- Source NDC Code(s): 0904-6720
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated July 5, 2024
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
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- more than 4,000 mg of acetaminophen in 24 hours
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- with other drugs containing acetaminophen
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- 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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- skin reddening
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- blisters
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- rash
If a skin reaction occurs, stop use and seek medical help right away.
Do not use
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- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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- if you have ever had an allergic reaction to this product or any of its ingredients
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Directions
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- do not take more than directed (see overdose warning)
adults and children 12 years and over
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- take 2 caplets every 6 hours while symptoms last
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- do not take more than 6 caplets in 24 hours, unless directed by a doctor
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- do not use for more than 10 days unless directed by a doctor
children under 12 years
ask a doctor
- Other information
- Inactive ingredients
- Questions or comments?
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HOW SUPPLIED
Acetaminophen 500 mg Tablet
- NDC: 71335-9644-1: 20 Tablets in a BOTTLE
- NDC: 71335-9644-2: 15 Tablets in a BOTTLE
- NDC: 71335-9644-3: 40 Tablets in a BOTTLE
- NDC: 71335-9644-4: 100 Tablets in a BOTTLE
- NDC: 71335-9644-5: 30 Tablets in a BOTTLE
- NDC: 71335-9644-6: 45 Tablets in a BOTTLE
- NDC: 71335-9644-7: 50 Tablets in a BOTTLE
- NDC: 71335-9644-8: 60 Tablets in a BOTTLE
- NDC: 71335-9644-9: 90 Tablets in a BOTTLE
- NDC: 71335-9644-0: 250 Tablets in a BOTTLE
Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504 - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71335-9644(NDC:0904-6720) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg Inactive Ingredients Ingredient Name Strength CARNAUBA WAX (UNII: R12CBM0EIZ) STARCH, CORN (UNII: O8232NY3SJ) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) STEARIC ACID (UNII: 4ELV7Z65AP) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) Product Characteristics Color WHITE Score no score Shape OVAL Size 16mm Flavor Imprint Code L484 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71335-9644-1 20 in 1 BOTTLE; Type 0: Not a Combination Product 02/21/2023 2 NDC:71335-9644-2 15 in 1 BOTTLE; Type 0: Not a Combination Product 02/21/2023 3 NDC:71335-9644-3 40 in 1 BOTTLE; Type 0: Not a Combination Product 02/21/2023 4 NDC:71335-9644-4 100 in 1 BOTTLE; Type 0: Not a Combination Product 02/21/2023 5 NDC:71335-9644-5 30 in 1 BOTTLE; Type 0: Not a Combination Product 02/21/2023 6 NDC:71335-9644-6 45 in 1 BOTTLE; Type 0: Not a Combination Product 02/21/2023 7 NDC:71335-9644-7 50 in 1 BOTTLE; Type 0: Not a Combination Product 02/21/2023 8 NDC:71335-9644-8 60 in 1 BOTTLE; Type 0: Not a Combination Product 02/21/2023 9 NDC:71335-9644-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 02/21/2023 10 NDC:71335-9644-0 250 in 1 BOTTLE; Type 0: Not a Combination Product 02/21/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 07/26/2018 Labeler - Bryant Ranch Prepack (171714327) Registrant - Bryant Ranch Prepack (171714327) Establishment Name Address ID/FEI Business Operations Bryant Ranch Prepack 171714327 REPACK(71335-9644) , RELABEL(71335-9644)