Label: CHILDRENS PAIN AND FEVER- acetaminophen liquid

  • 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 December 31, 2020

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

View All Sections
  • Drug FactsActive ingredient

    Active ingredient

    (in each 5 mL = 1 teaspoonful)

    Acetaminophen 160 mg

  • Purpose

    Pain reliver/fever reducer

  • Keep out of reach of children.

    Keep out of reach of children.

  • Uses

    temporarily reduces

    • fever
    • relieves minor aches and pains to:
    • the common cold
    • flu
    • headache
    • sore throat
    • toothache
  • Warnings

    Liver warning
    This product contains acetaminophen. Severe liver
    damage may occur if your child takes: ■ more than 5
    doses in 24 hours, which is the maximum daily amount
    ■ with other drugs containing acetaminophen

    Allergy alert
    Acetaminophen may cause severe skin reactions.
    Symptoms may include: ■ skin reddening ■ blisters
    ■ rash. If skin reaction occurs, stop use and seek
    medical help right away

    Sore throat warning
    If sore throat is severe, persists for more than 2 days, is
    accompanied or followed by fever, headache, rash,
    nausea or vomiting, consult a doctor promptly.

  • 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 your child is allergic to acetaminophen or any of the inactive ingredients in this product.
  • Ask a doctor before use if your child has

    liver disease

  • Ask a doctor or pharmacist before use if your child is

    taking the blood thinning drug warfarin.

  • When using this product do not exceed recommended dose (see overdose warning)Stop use and ask a doctor if

    • pain gets worse or lasts more than 5 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.

  • 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 right awway. (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

    • This product does not contain directions or complete warnings for adult use.
    • shake well before using
    • mL = milliliter; tsp = teaspoonful
    • find right dose on chart below. If possible, use weight to dose; otherwise, use age.
    • if needed, repeat dose every 4 hours while symptoms last
    • do not give more than 5 times in 24 hours
    • do not give for more than 5 days unless directed by a doctor
     Weight (lb) Age (yr) Dose (mL or tsp)*
     under 24 under 2 years ask a doctor
     24-35 2-3 years 5 mL (1 tsp)
     36-47 4-5 years 7.5 mL (1 1/2 tsp)
     48-59 6-8 years 10 mL (2 tsp)
     60-71 9-10 years 12.5 mL (2 1/2 tsp)
     72-95 11 years 15 mL (3 tsp)

    * or use as directed

    Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

  • Other information

    • each 5 mL (1 tsp) contains: sodium 3 mg
    • store between 20-25°C (68-77°F)
    • do not refrigerate
  • Inactive ingredients

    anhydrous citric acid, butylparaben, FD and C red # 40, flavor, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

  • Marcs Childrens Pain and Fever Product Label

    NDC 68998-525-24

    Compare to the active ingredient in childrens Tylenol® oral suspension*

    MARCS

    Childrens

    Pain and Fever

    Pain Reliver / Fever Reducer

    Acetaminophen Oral Suspension

    • Alcohol-Free
    • Ibuprofen Free
    • Asprin Free

    For Ages 2 to 11

    CHERRY FLAVOR

    4 FL OZ (118 mL)

    160 mg per 5 mL

    DO NOT USE IF PRINTED NECKBAND IS BROKEN OR MISSING

    * This product is not manufactured or distributed by McNeil Consumer Healthcare, Distributer of Childrens Tylenol® Oral Suspension

    Distributed by:

    Marc Glassman, Inc.

    West 130th Street

    Cleveland, OH 44130

    BX-045

    LR-076

    Lot:

    Exp:

    68993-524 118mL bottle

    68993-524 118mL box

    rres

  • INGREDIENTS AND APPEARANCE
    CHILDRENS PAIN AND FEVER 
    acetaminophen liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68998-525
    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)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68998-525-24118 mL in 1 BOTTLE; Type 0: Not a Combination Product10/10/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34310/10/2014
    Labeler - Marc Glassman, Inc. (094487477)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!