Label: PAIN RELIEVER- acetaminophen solution

  • NDC Code(s): 21130-945-19
  • Packager: Better Living Brands, LLC
  • 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 September 24, 2021

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  • Active ingredient (in each 30 mL)

    Acetaminophen 1,000 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

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

    Liver warning: This product contains acetaminophen. 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 reactions. Symptoms may include:

    • blisters
    • rash
    • skin reddening

    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 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 reach of children.

    In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt 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
    • mL = milliliter; FL OZ = fluid ounce
    • only use the dose cup provided
    • adults and children 12 years and over
      • take 30 mL every 6 hours while symptoms last
      • do not take more than 90 mL in 24 hours, unless directed by a doctor
      • do not take for more than 10 days unless directed by a doctor
    • children under 12 years: do not use
  • Other information

    • each 30 mL contains: sodium 11 mg
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • use by expiration date on package
  • Inactive ingredients

    anhydrous citric acid, flavor, glycerin, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sodium saccharin, sucralose

  • Questions or comments?

    1-800-426-9391

  • Principal display panel

    Signature
    care®
    Quality
    Guaranteed

    Compare to
    Tylenol® Extra Strength
    active ingredient*

    NDC 21130-945-19

    Extra Strength
    Pain Reliever
    ACETAMINOPHEN     1,000 mg

    Pain Reliever/Fever Reducer

    CHERRY FLAVOR

    • Alcohol Free
    • Dye Free
    • Contains no aspirin

    F-045-19 REV1120A

    8 FL OZ (237 mL)

    TAMPER EVIDENT: DO NOT USE IF PRINTED NECK
    WRAP IS BROKEN OR MISSING

    B-045-19
    REV1120A

    *This product is not manufactured or distributed by Johnson &
    Johnson Corporation, distributors of Tylenol® Extra Strength.
    50844               REV1120A04519

    DISTRIBUTED BY BETTER LIVING BRANDS LLC
    P.O. BOX 99, PLEASANTON, CA 94566-0009
    1-888-723-3929 www.betterlivingbrandsLLC.com
    QUALITY & SATISFACTION 100% GUARANTEED
    OR YOUR MONEY BACK

    Signature Care 44-045

    Signature Care 44-045

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEVER 
    acetaminophen solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-945
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN1000 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-945-19237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/15/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34307/15/2021
    Labeler - Better Living Brands, LLC (009137209)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305manufacture(21130-945) , pack(21130-945)
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