Label: ACETAMINOPHEN 325MG- acetaminophen tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 10135-123-01 - Packager: Marlex Pharmaceuticals Inc
- Category: HUMAN OTC DRUG LABEL
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 February 3, 2021
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient (in each tablet)
- Purpose
- Uses
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Warnings
Liver warning: this product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
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.
- if you are allergic to acetaminophen or any of the inactive ingredients in this product.
Drug Facts (continued)
Ask a doctor before use if you have liver disease .
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 symptoms occur.
- Redness or swelling is present.
These could be signs of a serious condition.
Overdose warning:
Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
- more than 4,000 mg of acetaminophen in 24 hours
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Directions
Do not take more than directed (see overdose warning)
Adults and Children 12 years and over:
- Take 2 tablets every 6 hours while symptoms last.
- Do not take more than 12 tablets in 24 hours, unless directed by a doctor.
- Do not use for more than 10 days unless directed by a doctor.
Children 6-11 years:
- Take 1 tablet every 4 to 6 hours while symptoms last.
- Do not take more than 5 tablets in 24 hours.
Children under 6 years:
- ask a doctor.
- Take 2 tablets every 6 hours while symptoms last.
- Other Information
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN 325MG
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10135-123 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 CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) STEARIC ACID (UNII: 4ELV7Z65AP) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) Product Characteristics Color white Score 2 pieces Shape ROUND Size 8mm Flavor Imprint Code MLX123 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10135-123-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 04/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 04/01/2018 Labeler - Marlex Pharmaceuticals Inc (782540215)
