Label: ACETAMINOPHEN 325MG RS- acetaminophen 325mg tablet
- NDC Code(s): 63739-087-02
- Packager: McKesson Corporation dba SKY Packaging
- This is a repackaged label.
- Source NDC Code(s): 69168-010
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 4, 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 tablet)
- Purpose
- Uses
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Warnings
Liver Warning: This product contains acetaminophen. Severe liver damage may occur if
- adult takes more than 4,000 mg in 24 hours
- child takes more than 5 doses in 24 hours
- taken with other drugs containing acetaminophen
- adult has 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
- if you are allergic to acetamiophen
- with other products containing acetaminophen (prescription or nonprescription).
If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Stop use and ask a doctor if
- symptoms do not improve
- pain gets worse or lasts for more than 10 days
- pain gets worse or lasts more than 5 days in children under 12 years
- fever gets worse or lasts for more than 3 days
- new symptoms occur
- redness or swelling is present
- a rare sensitivity reaction occurs
- You may report side effects to 1-888-952-0050
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Directions
Adults and children 12 years of age and over: Take 2 tablets every 4 to 6 hours.
Do not take more than 10 tablets in 24 hours.
Children 6-11 years of age: Take 1 tablet every 4 to 6 hours as needed.
Do not take more than 5 tablets in 24 hours.
Children under 6 years of age: Do not use this regular strenght product. This will provide more than the recommended dose (overdose) and could cause serious health problems.
- Other information
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN 325MG RS
acetaminophen 325mg tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63739-087(NDC:69168-010) 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 STARCH, CORN (UNII: O8232NY3SJ) POVIDONE (UNII: FZ989GH94E) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white (white) Score no score Shape ROUND (Round Circle) Size 11mm Flavor Imprint Code AZ;010 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63739-087-02 30 in 1 BOX 07/12/2021 1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 07/12/2021 Labeler - McKesson Corporation dba SKY Packaging (140529962) Establishment Name Address ID/FEI Business Operations Legacy Pharmaceutical Packaging, LLC 143213275 repack(63739-087) , relabel(63739-087)
