Label: ACETAMINOPHEN 325MG- acetaminophen tablet
- NDC Code(s): 10135-828-01
- Packager: Marlex Pharmaceuticals Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated February 1, 2026
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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.
Severe liver damage may occur if
- adult takes more than 12 tablets in 24 hours, which is the maximum daily amount
- child takes more than 5 doeses in 24 hours
- taken with other drugs containing acetaminophen
- adult has 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.
Stop use and ask a doctor if
- Pain gets worse or lasts more than 10 days in adults and children.
- Pain gets worse or lasts more than 5 days in children under 12 years.
- 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.
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Directions
Do not take more than directed
Adults and Children 12 years and over:
- Take 2 tablets every 4 to 6 hours while symptoms last.
- Do not take more than 12 tablets in 24 hours
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 6years:
Do not use this adult regular strength product in children under 6 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage.
- 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:10135-828 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 K30 (UNII: U725QWY32X) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) Product Characteristics Color white Score no score Shape ROUND Size 10mm Flavor Imprint Code C;19 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10135-828-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2026 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 02/01/2026 Labeler - Marlex Pharmaceuticals Inc (782540215)
