Label: ACETAMINOPHEN tablet
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NDC Code(s):
68071-2481-2,
68071-2481-3,
68071-2481-4,
68071-2481-5, view more68071-2481-7
- Packager: NuCare Pharmaceuticals,Inc.
- This is a repackaged label.
- Source NDC Code(s): 57896-104
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated September 19, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
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Warnings
Liver warning:
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4,000 mg (12 tablets) of acetaminophen in 24 hours
- 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
• blisters • rash 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.
Ask a doctor before use if you have liver disease
Ask a doctor or pharmacist before use if you
are taking the blood thinning drug warfarin.
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 symptom occur
- redness or swelling is present
These could be signs of a serious condition.
If pregnant or breast-feeding,ask a health professional before use.
- Directions
- Other Information
- Inactive Ingredients
- Package Label
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68071-2481(NDC:57896-104) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg Inactive Ingredients Ingredient Name Strength POVIDONE (UNII: FZ989GH94E) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white (WHITE) Score 2 pieces Shape ROUND (Round) Size 10mm Flavor Imprint Code 44;104 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68071-2481-5 50 in 1 BOTTLE; Type 0: Not a Combination Product 07/23/2021 2 NDC:68071-2481-4 40 in 1 BOTTLE; Type 0: Not a Combination Product 07/23/2021 3 NDC:68071-2481-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 07/23/2021 4 NDC:68071-2481-2 20 in 1 BOTTLE; Type 0: Not a Combination Product 07/23/2021 5 NDC:68071-2481-7 25 in 1 BOTTLE; Type 0: Not a Combination Product 07/23/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 04/01/2020 Labeler - NuCare Pharmaceuticals,Inc. (010632300) Establishment Name Address ID/FEI Business Operations NuCare Pharmaceuticals,Inc. 010632300 repack(68071-2481)
