Label: ACETAMINOPHEN capsule

  • 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 July 14, 2017

If you are a consumer or patient please visit this version.

  • Active ingredient

    (in each Gelcap)
    Acetaminophen, USP 500 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

    ■ temporarily relieves minor aches and pains due to:
    ■ headache
    ■ muscular aches
    ■ backache
    ■ minor pain of arthritis
    ■ the common cold
    ■ toothache
    ■ premenstrual and menstrual cramps
    ■ temporarily reduces fever

  • Liver warning

    This product contains acetaminophen. The maximum daily dose of this product is 6 gelcaps (3,000 mg) in 24 hours. Severe liver damage may occur if you take:
    ■ more than 4,000 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 reaction. Symptoms may include:
    ■ skin reddening
    ■ blisters
    ■ rash
    If a skin reaction occurs, stop use and seek medical help right away.

  • Do not use

    ■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    ■ if you have ever had an allergic reaction to this product or any of its ingredients

  • 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

    ■ pain gets worse or lasts more than 10 days
    ■ fever gets worse or lasts more than 3 days
    ■ new symptoms occur
    ■ redness or swelling is present
    These could be signs of a serious condition.

  • If pregnant or breast-feeding

    ask a health professional before use.

  • Keep out of the reach of children.

  • Overdose warning

    Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a 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

    ■ do not take more than directed (see overdose warning)
    adults and children 12 years and over
    ■ take 2 gelcaps every 6 hours while symptoms last
    ■ do not take more than 6 gelcaps in 24 hours, unless directed by a doctor
    ■ do not use for more than 10 days unless directed by a doctor
    children under 12 years
    ask a doctor

  • Other information

    ■ store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature.
    ■ avoid high humidity
    ■ see end panel for lot number and expiration date

  • Inactive ingredients

    ammonium hydroxide, black iron oxide, black iron oxide irradiated, colloidal silicon dioxide, croscarmellose sodium, gelatin, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, hypromellose, iron oxide red, isopropyl alcohol, n-butyl alcohol, polyethylene glycol, povidone k-30, pregelatinized starch, propylene glycol, shellac glaze (modified), stearic acid, titanium dioxide, yellow iron oxide.

  • Questions or comments?

    call 1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST

  • EXTRA STRENGTH PAIN RELIEVER ACETAMINOPHEN, USP 500 mg Pain Reliever/Fever Reducer 24 GELCAPS 500 mg each

    24 Count

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-987
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    AMMONIA (UNII: 5138Q19F1X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    GELATIN (UNII: 2G86QN327L)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POVIDONE K30 (UNII: U725QWY32X)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    SHELLAC (UNII: 46N107B71O)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Product Characteristics
    Colorgray (one red opaqe and one blue-gray hard gelatin shells) Scoreno score
    ShapeCAPSULESize19mm
    FlavorImprint Code G1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55315-987-2424 in 1 BOTTLE; Type 0: Not a Combination Product08/17/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34308/17/2017
    Labeler - FFREDS, INC (005866116)