Label: CHILDRENS PAIN RELIEF ORAL SUSPENSION- acetaminophen suspension

  • NDC Code(s): 68016-240-04
  • Packager: Pharmacy Value Alliance, LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 29, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each 5 mL =1 teaspoonful)
    Acetaminophen   160 mg

  • PURPOSE

    Purpose
    Acetaminophen.... 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 a 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,

  • DO NOT USE

    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 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
    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
    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; 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 adoctor.

    Weight (Ib)       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 Y2 tsp)
    48-59             6-8 years          10 mL (2 tsp)
    60-71             9-10 year          12.5 mL (2Y2 tsp)
    72-95             11 year             15 mL (3 tsp)

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

  • OTHER SAFETY INFORMATION

    Other information
    ■ each 5 mL (1 tsp) contains: sodium 3 mg
    ■ store between 20-25°C (68-77oF)
    ■ do not refrigerate
    Keep carton for full directions for use.

  • INACTIVE INGREDIENT

    Inactive ingredients anhydrous citric acid,
    butylparaben, FD&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

  • QUESTIONS

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

  • Principal Display Panel

    Premier
    Value®

    Children's
    Pain Relief

    PAIN RELIEVER – FEVER REDUCER
    ACETAMINOPHEN

    ORAL SUSPENSION

    Cherry Flavor

    Premier
    Value®

    Compare to the active
    ingredients in Children's
    TYLENOL® Oral Suspension**

    Ages 2-11 years

    Children's
    Pain Relief

    PAIN RELIEVER – FEVER REDUCER
    ACETAMINOPHEN

    ORAL SUSPENSION
    160 mg per 5 mL

    • Alcohol Free
    • Aspirin Free
    • Ibuprofen Free

    Use ONLY enclosed
    dosage cup

    Cherry Flavor
    4 FL OX (118 mL)

    INDEPENDENTLY TESTED
    PV
    SATISFACTION GUARANTEED

    DO NOT USE IF PRINTED NECK BAND IS

    BROKEN OR MISSING

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

    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
    Children's Tyleno!® Oral Suspension.

    BX-072

    711198

    10/17

    Product Label

    240-04 Outer

    240-04 Inner

                          Premier Value® Children's Pain Relief ACETAMINOPHEN ORAL SUSPENSION Cherry Flavor

    240-04 Outer

    240-04 Inner

    end res

  • INGREDIENTS AND APPEARANCE
    CHILDRENS PAIN RELIEF ORAL SUSPENSION 
    acetaminophen suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-240
    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)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCROSE (UNII: C151H8M554)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-240-041 in 1 CARTON10/01/2018
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01310/01/2018
    Labeler - Pharmacy Value Alliance, LLC (101668460)
    Registrant - AptaPharma Inc. (790523323)
    Establishment
    NameAddressID/FEIBusiness Operations
    AptaPharma Inc.790523323manufacture(68016-240)