Label: ACETAMINOPHEN 325MG RS- acetaminophen 325mg tablet
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- NDC Code(s): 69168-010-50, 69168-010-60
- Packager: Allegiant Health
- 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 January 7, 2019
If you are a consumer or patient please visit this version.
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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.
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN 325MG RS
acetaminophen 325mg tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) 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:69168-010-60 1 in 1 CARTON 04/15/2016 1 60 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:69168-010-50 1 in 1 CARTON 04/15/2016 2 50 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 04/15/2016 Labeler - Allegiant Health (079501930)
