Label: ACETAMINOPHEN solution

  • NDC Code(s): 60687-571-24, 60687-571-37, 60687-571-42, 60687-571-48, view more
    60687-571-53, 60687-571-56
  • Packager: American Health Packaging
  • 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 29, 2021

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

  • Active ingredient

    (in each 10.15 mL cup) Acetaminophen, USP 325 mg

    (in each 20.30 mL cup) Acetaminophen, USP 650 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
  • Warnings (10.15 mL unit dose cups)

    Liver Warning: This product contains acetaminophen. The maximum daily dose of this product is 10 unit dose cups (3,250 mg) in 24 hours for adults or 5 unit dose cups (1,625 mg) in 24 hours for children, which is the maximum daily amount for this product. Severe liver damage may occur if

    • adult takes more than 10 unit dose cups (101.50 mL) in 24 hours
    • child takes more than 5 unit dose cups (50.75 mL) in 24 hours, which is the maximum daily amount
    • 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.

  • Warnings (20.30 mL unit dose cups)

    Liver Warning: This product contains acetaminophen. The maximum daily dose of this product is 5 unit dose cups (3,250 mg) in 24 hours for adults, which is the maximum daily amount for this product. Severe liver damage may occur if

    • adult takes more than 5 unit dose cups (101.50 mL) 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

    • 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 are allergic to acetaminophen or any of the inactive ingredients in this product
  • Ask a doctor

    before use if the 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

    • pain gets worse or last for more than 10 days in adults
    • pain gets worse or last for 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

    These could be signs of a serious condition.

    If pregnant or breast-feeding

    ask a health professional before use.

  • Keep Out of Reach of Children

    Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

    Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions (10.15 mL unit dose cups)

    • do not take more than directed (see overdose warning)

    adults and children 12 years and over

    • take 2 unit dose cups (20.30 mL) every 4 to 6 hours while symptoms last
    • do not take more than 10 unit dose cups (101.50 mL0 in 24 hours, unless directed by a doctor
    • do not use for mor than 10 days unless directed by a doctor

    children 6 years to under 12 years

    • take 1 unit dose cup (10.15 mL) every 4 to 6 hours while symptoms last
    • do not take more than 5 unit does cups (50.75 mL) in 24 hours
    • do not use for more than 5 days unless directed by a doctor

    children under 6 years

    ask a doctor

  • Directions (20.30 mL unit dose cups)

    • do not take more than directed (see overdose warning)

    adults and children 12 years and over

    • take 1 unit dose cups (20.30 mL) every 4 to 6 hours while symptoms last
    • do not take more than 5 unit dose cups (101.50 mL0 in 24 hours, unless directed by a doctor
    • do not use for mor than 10 days unless directed by a doctor

    children 6 years to under 12 years

    ask a doctor

  • Other Information

    • each 10.15 mL contains: sodium 33.5 mg
    • each 22.30 mL contains: sodium 67 mg
    • Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F)
    • Protect from light
    • DO NOT USE IF SEAL IS BROKEN
    • This drug product is supplied in 10.15 mL unit dose cups as:100 cups (10 x 10) NDC 60687-571-56
    • This drug product is supplied in 20.30 mL unit dose cups as:100 cups (10 x 10) NDC 60687-571-37
  • Inactive Ingredients

    anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, artificial cherry flavor, glycerin, methylparaben, polyethylene glycol, propylparaben, purified water, sodium citrate, sodium saccharin

  • Packaging Information

    American Health Packaging unit dose cups (see Other Information section) contain drug product from Woodfield Pharmaceutical LLC as follows:
    (325 mg per 10.15 mL / 100UD) NDC 60687-571-56 packaged from NDC 72207-114
    (650 mg per 20.30 mL / 100UD) NDC 60687-571-37 packaged from NDC 72207-114

    Distributed by:
    American Health Packaging
    Columbus, Ohio 43217

    8457156/0621F
    8457137/0621F

  • Package/Label Principal Display Panel - Tray

    325mg per 10.15mL Acetaminophen Oral Solution Label

    Acetaminophen
    Oral Solution, USP
    Pain Reliever/Fever Reducer

    325 mg/10.15 mL

    Artificial Cherry Flavor

    FOR INSTITUTIONAL USE ONLY

    Store at 20°C to 25°C (68°F to 77°F),
    excursions permitted between
    15°C and 30°C (between 59°F and 86°F).
    Protect from light.

    8457156/0621F

    650 mg per 20.30 mL Acetaminophen Oral Solution Label

    Acetaminophen
    Oral Solution, USP
    Pain Reliever/Fever Reducer

    650 mg/20.30 mL

    Artificial Cherry Flavor

    FOR INSTITUTIONAL USE ONLY

    Store at 20°C to 25°C (68°F to 77°F),
    excursions permitted between
    15°C and 30°C (between 59°F and 86°F).
    Protect from light.

    8457137/0621F

  • Package/Label Principal Display Panel – Cup – 325 mg per 10.15 mL

    325 mg per 10.15 mL Acetaminophen Oral Solution Cup

    NDC 60687- 571-42

    Acetaminophen
    Oral Solution, USP
    Pain Reliever/Fever Reducer

    325 mg/10.15 mL
    Delivers 10.15 mL

    Protect from light.

    See package Drug Facts insert for full
    prescribing information and storage.

    For Institutional Use Only.

    American Health Packaging
    Columbus, OH 43217

    0457156/0620

  • Package/Label Principal Display Panel – Cup – 650 mg per 20.30 mL

    650 mg per 20.30 mL Acetaminophen Oral Solution Cup

    NDC 60687- 571-24

    Acetaminophen
    Oral Solution, USP
    Pain Reliever/Fever Reducer

    650 mg/20.30 mL
    Delivers 20.30 mL

    Protect from light.

    See package Drug Facts insert for full
    prescribing information and storage.

    For Institutional Use Only.

    American Health Packaging
    Columbus, OH 43217

    0457137/0620

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60687-571
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60687-571-5610 in 1 CASE07/01/2021
    1NDC:60687-571-4810 in 1 TRAY
    1NDC:60687-571-4210.15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    2NDC:60687-571-3710 in 1 CASE07/01/2021
    2NDC:60687-571-5310 in 1 TRAY
    2NDC:60687-571-2420.3 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34307/01/2021
    Labeler - American Health Packaging (929561009)