Label: INFANTS PAIN RELIEF ORAL SUSPENSION GRAPE FLAVOR- acetaminophen suspension

  • 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 October 24, 2018

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each 5 mL)    Acetaminophen 160 mg

  • PURPOSE

    Purpose    Pain reliever/fever reducer

  • INDICATIONS & USAGE

    Uses temporarily:

    ■ reduces fever
    ■ relieves minor aches and pains due to:
       ■ the common cold ■ flu  ■ headache ■ sore throat
       ■ toothache

  • WARNINGS

    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 askin 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

    Do not use
    ■ with any other drug containing acetaminophen (prescription
    or nonprescription). If you are not sure whether adrug
    contains acetaminophen, ask a doctor or pharmacist
    ■ if your child is allergic to acetaminophen or any of the
    inactive ingredients in this product.

  • ASK DOCTOR

    Ask a doctor before use if your child has liver disease

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if your child is taking
    the blood thinning drug warfarin

  • WHEN USING

    When using this product do not exceed recommended dose
    (see overdose warning)

  • STOP USE

    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.

  • Keep out of reach of children

    Keep out of reach of children.

  • OVERDOSAGE

    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.

  • DOSAGE & ADMINISTRATION

    Directions
    ■ this product does not contain
    directions or complete warnings for
    adult use.
    ■ shake well before using
    ■ mL = milliliter
    ■ 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

    Dosing Chart
     Weight (lb) Age (yr) Dose (mL)*
     Under 24 Under 2 years Ask a doctor
     24 - 35 2 -3 years 5 mL

    *or as directed by
    Attention: use only enclosed dosing
    syringe specifically designed for use
    with this product. Do not use any other
    dosing device.

  • OTHER SAFETY INFORMATION

    Other information
    ■ each 5 ml contains: sodium 3 mg
    ■ store between 20-25°C (68-7TF)
    ■ do not refrigerate

  • INACTIVE INGREDIENT

    Inactive ingredients
    anhydrous citric acid, butylparaben,
    D&C Red # 33, FD&C Blue # 1, flavor,
    glycerin, high fructose corn syrup,
    microcrystalline cellulose and
    carboxymethylcellulose sodium,
    propylene glycol, purified water, sodium
    benzoate, sorbitol solution, sucralose,
    xanthan gum.

  • QUESTIONS

    Questions? Call weekdays from 9:30
    AM to 4:30 PM EST at 1-877-798-5944

  • Principal Display Panel

    Premier

    Value®

    Infants'

    Pain Relief

    PAIN RELIEVER - FEVER REDUCER

    ACETAMINOPHEN

    ORAL SUSPENSION

    Grape Flavor

    Premier

    Value®

    Compare to Infants'

    TYLENOL® Oral Suspension

    active ingredient**

    Infants'

    Pain Relief

    PAIN RELIEVER - FEVER REDUCER

    ACETAMINOPHEN

    ORAL SUSPENSION

    160 mg per 5 mL

    • Alcohol Free
    • Aspirin Free
    • Ibuprofen Free

    Use ONLY
    enclosed syringe

    Grape

    Flavor

    2 FL OZ (59 mL)

    INDEPENDENTLY TESTED
    PV
    SATISFACTION GUARANTEED

    LOT:

    EXP:

    DO NOT USE IF PRINTED NECK BAND IS BROKEN OR MISSING

    BX-077

    DISTRIBUTED BY:
    PHARMACY VALUE ALLIANCE, LLC
    407 EAST LANCASTER AVENUE,
    WAYNE, PA 19087

    **This product is not manufactured or distributed by
    McNeil Consumer Healthcare, distributor of Infants'
    Tylenol® Oral Suspension.

    IMPORTANT INSTRUCTIONS

    1 Remove the cap. 

    2 Insert the syringe
    tip through the
    opening at the
    top of the bottle.

    3 Turn the bottle
    upside down and
    fill syringe to
    dose.

    Use enclosed
    syringe only.

    Do not use other
    dosing devices.

    INDEPENDENTLY TESTED
    PV
    SATISFACTION GUARANTEED

    If for any reason you are not satisfied
    with this product, please return it to the
    store where purchased for a full refund.

    Product Label - Outer

    242-02 Outer

    Product Label - Inner

    242-02 Inner

                                                 Premier Value® Infants' Pain Relief

    end res

  • INGREDIENTS AND APPEARANCE
    INFANTS PAIN RELIEF ORAL SUSPENSION GRAPE FLAVOR 
    acetaminophen suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-242
    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)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    MICROCRYSTALLINE CELLULOSE (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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-242-021 in 1 CARTON10/01/2018
    159 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34310/01/2018
    Labeler - Pharmacy Value Alliance, LLC (101668460)