ACETAMINOPHEN 325MG RS- acetaminophen 325mg 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)

Acetaminophen 325mg

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

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 acetamiophen
  • with other products 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 user has

liver disease.

Ask a doctor or pharmacist before use if

the user is 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 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

If pregnant or breast-feeding

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children

Keep out of reach of children. In  case of accidental overdose, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. 

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

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

Principal Display Panel

Pain Relief

Pain Relief

Pain Relief

Pain Relief


ACETAMINOPHEN 325MG  RS
acetaminophen 325mg tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-010
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen325 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 Circle) Size11mm
FlavorImprint Code AZ;010
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69168-010-601 in 1 CARTON04/15/2016
160 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:69168-010-501 in 1 CARTON04/15/2016
250 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:69168-010-301 in 1 CARTON12/15/2021
330 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: 184eea4e-3a11-479e-9454-b6782d10e243
Set id: 61c6d281-e59b-4277-bbce-f71c12c2a56d
Version: 3
Effective Time: 20190107
 
Allegiant Health