ACETAMINOPHEN 500MG ES- acetaminophen 500mg tablet 
Allegiant Health

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.

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Drug Facts

Active Ingredient (in each tablet)

Acteminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

temporary relief of minor aches and pains associated with

Warnings

Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take 

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

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.

Ask a doctor before use if you have

liver disease

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin.

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

If pregnant or breast-feeding

ask a health professional before use.

Keep out of reach of children

 In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Other information

Inactive ingredients

corn starch, povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Principal Display Panel

Pain Relief

Pain Relief

Pain Relief

Pain Relief


ACETAMINOPHEN 500MG  ES
acetaminophen 500mg tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-011
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen500 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
POVIDONE (UNII: FZ989GH94E)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
Colorwhite (White) Scoreno score
ShapeROUND (round) Size12mm
FlavorImprint Code AZ;011
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69168-011-501 in 1 CARTON04/15/2016
150 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:69168-011-401 in 1 CARTON04/15/2016
240 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:69168-011-241 in 1 CARTON12/15/2021
324 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34304/15/2016
Labeler - Allegiant Health (079501930)

Revised: 1/2019
Document Id: efa6acc4-448b-4f69-b769-534cd3bfe802
Set id: 91acc132-01b6-467b-9af5-70f4dc93e087
Version: 3
Effective Time: 20190108
 
Allegiant Health