Label: ACETAMINOPHEN 325MG RS- acetaminophen 325mg tablet

  • 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.

  • Active Ingredient (in each tablet)

    Acetaminophen 325mg

  • Purpose

    Pain reliever/fever reducer


  • Uses

    temporary relief of minor aches and pains associated with:

    • headache
    • backache
    • muscular aches
    • minor pain of arthritis
    • the common cold
    • toothache
    • premenstrual and menstrual cramps
    • temporarily reduces fever
  • 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.

    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

    • store at room temperature
    • do not use if imprinted safety seal under cap is broken or missing
  • Inactive ingredients

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

  • Principal Display Panel

    Acetaminophen 325mg

    Acetaminophen 325mg


  • INGREDIENTS AND APPEARANCE
    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
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34304/15/2016
    Labeler - Allegiant Health (079501930)