Label: MOMMYS BLISS INFANTS PAIN AND FEVER- acetaminophen suspension

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 11, 2024

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

  • Active Ingredient

    Active ingredient: (in each 5 mL) Acetaminophen 160mg

  • 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) Prompt medical attention is critical even if you do not notice any signs or symptoms.

  • Purpose:

    Pain reliever/fever reducer

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

  • Stop use and ask a doctor.

    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
    ▪ redness or swelling is present
    ▪ any new symptoms appear
    These could be signs of a serious condition.

  • Inactive ingredients:

    anhydrous citric acid, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, natural flavors, organic elderberry juice
    concentrate, purified water, sodium benzoate, sucrose, xanthan gum

  • 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, 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 before use if your child is taking the blood thinning drug warfarin
    When using this product do not exceed recommended dose (see overdose warning)

  • Dosing & Directions


    Directions
    ▪ this product does not contain directions or complete warnings
    for adult use
    ▪ do not give more than directed (see overdose warning)
    ▪ shake well before using
    ▪ mL=milliliter
    ▪ find right dose on chart below
    ▪ if possible, use weight to dose; otherwise, use age
    ▪ remove cap and seal, then insert the adapter plug by pushing down
    firmly until a tight seal is formed
    ▪ top of plug should be flush with bottle neck and not removeable
    ▪ push air out of syringe and insert syringe tip into adapter plug opening
    ▪ flip bottle upside down
    ▪ pull plunger of syringe up to correct dose
    ▪ dispense liquid slowly into child’s mouth, toward inner cheek
    ▪ repeat dose every 4 hours while symptoms last
    ▪ do not give more than 5 times in 24 hours
    ▪ replace cap tightly to maintain child resistance
    Weight (lb) Age (yr) Dose (mL)*
    under 24 lbs under 2 years ask a doctor
    24-35 lbs 2-3 years 5 mL
    *or as directed by a doctor
    Attention: use only enclosed syringe specifically designed for use with this product. Do not use any other dosing device.

  • Usage

    Purpose: Pain reliever/fever reducer

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

  • Infants' Pain and Fever Acetaminophen 160mg per 5mL oral suspension

    Pain Reliever - Fever Reducer, 2 floz (59 mL) plastic bottle in retail carton, Natural Berry Flavor, Dosing Syringe included

    retail carton

    bottle

    flap

  • INGREDIENTS AND APPEARANCE
    MOMMYS BLISS INFANTS PAIN AND FEVER 
    acetaminophen suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71444-893
    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
    WATER (UNII: 059QF0KO0R)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    AMERICAN ELDERBERRY (UNII: 7610Y219OC)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    Colorpurple (light purple to light brown liquid) Score    
    ShapeSize
    FlavorBERRY (sweet berry flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71444-893-0159 mL in 1 BOTTLE; Type 0: Not a Combination Product02/19/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01302/19/2024
    Labeler - Mom Enterprises, LLC. (135903776)