Label: ACETAMINOPHEN 500MG ES- acetaminophen 500mg tablet
- NDC Code(s): 69168-011-24, 69168-011-40, 69168-011-50
- Packager: Allegiant Health
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 8, 2019
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- 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 you take
- more than 4000 mg 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
- if you are allergic to acetaminophen
- with any other drug 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 get 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
- more than 4000 mg of acetaminophen in 24 hours
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Directions
- do not use more than directed (see overdose warning)
- adults and children 12 years and over: take 2 tablets every 4 to 6 hours. Do not take more than 8 tablets in 24 hours.
- Do not use more than 10 days unless directed by a doctor
- children under 12 years of age: do not use this extra strength 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 500MG ES
acetaminophen 500mg tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69168-011 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen 500 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) Size 12mm Flavor Imprint Code AZ;011 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69168-011-50 1 in 1 CARTON 04/15/2016 1 50 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:69168-011-40 1 in 1 CARTON 04/15/2016 2 40 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:69168-011-24 1 in 1 CARTON 12/15/2021 3 24 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 Drug M013 04/15/2016 Labeler - Allegiant Health (079501930)
