Label: CHILDRENS ACETAMINOPHEN ORAL SUSPENSION- acetaminophen suspension

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

Drug Label Information

Updated January 3, 2024

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 and relieves minor aches and pains due to:

    • the common cold
    • headache
    • toothache
    • flu
    • sore throat
  • 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.

    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

    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.

    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.

  • DOSAGE & ADMINISTRATION

    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
    • find right dose on chart below
    • for accurate dosing, use measuring cup provided. Do not use with any other dosing device.
    • give dose every 4 hours while symptoms last
    • if possible, use weight to dose; otherwise, use age
    • do not give more than 5 times in 24 hours
    WeightAgeDose
    under 24 lbs.under 2 yearsask a doctor
    24-35lbs.2-3 years5 mL
    36-47 lbs.4-5 years7.5 mL
    48-59 lbs.6-8 years10 mL
    60-71 lbs.9-10 years12.5 mL
    72-95 lbs.11 years15 mL

  • STORAGE AND HANDLING

    Other information

    store between 20-25°C (68-77°F)

  • INACTIVE INGREDIENT

    Inactive ingredients

    organic agave syrup, organic blueberry flavor, natural citrus extract, flavor, purified water

  • QUESTIONS

    Questions?1-855-436-3921

  • SPL UNCLASSIFIED SECTION

    *This product is not manufactured or distributed by Johnson & Johnson Corp., owner of the registered trademark Children's Tylenol® Oral Suspension Grape.

  • SPL UNCLASSIFIED SECTION

    Give it a SHAKE! We use clean ingredients so it's normal for them to separate and change color over time.

    Bottle is safety sealed with a perforated band around bottle. DO NOT use if bottle seal is distrubed or missing.

    Certified B Corporation

    CERTIFIED GLUTEN FREE GFCO.ORG

    CERTIFIED VEGAN VEGAN.ORG

    Patent Pending | Distributed by: Genexa Inc.

    Atlanta, GA 30318 | genexa.com

  • SPL UNCLASSIFIED SECTION

    Made in the USA with globally sourced ingredients

    NDC 69676-0069-9

  • PRINCIPAL DISPLAY PANEL

    Children's

    Genexa®

    MEDICINE MADE CLEAN

    Ages 2-11

    Acetaminophen

    160 mg per 5 mL | Oral Suspension

    Pain Reliever Fever Reducer

    Compare to active ingredient in Children's Tylenol® Oral Suspension Grape

    How we're different

    Made without: high fructose corn syrup, FD&C blue no. 1, D&C red no. 33 & more!

    Organic Blueberry Flavor

    Ibuprofen Free, Aspirin Free

    4 fl oz (118 mL) Dosing cup included

    39A_Pain-and-Fever_Childrens_Carton_R-20220113

  • INGREDIENTS AND APPEARANCE
    CHILDRENS ACETAMINOPHEN ORAL SUSPENSION 
    acetaminophen suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69676-0069
    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)  
    CITRUS FRUIT (UNII: XDK00Z8012)  
    BLUEBERRY (UNII: 253RUG1X1A)  
    AGAVE TEQUILANA JUICE (UNII: GVG8G0207O)  
    Product Characteristics
    Colorbrown (Golden) Score    
    ShapeSize
    FlavorBLUEBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69676-0069-91 in 1 CARTON05/10/2022
    1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01305/10/2022
    Labeler - Genexa Inc. (079751024)