Label: ACETAMINOPHEN 500MG ES- acetaminophen 500mg tablet
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- NDC Code(s): 69168-011-40, 69168-011-50
- 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 8, 2019
If you are a consumer or patient please visit this version.
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- 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
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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 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)
