Label: MULTI-SYMPTOM COLD AND FLU-KIDS- acetaminophen 320 mg, dextromethorphan hbr 5 mg, guaifenesin 100 mg suspension

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

Drug Label Information

Updated December 7, 2023

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each 10 mL)

    Acetaminophen 320 mg

    Dextromethorphan HBr, USP 5 mg

    Guaifenesin, USP 100 mg

  • PURPOSE

    Purposes

    Pain Reliever/Fever Reducer

    Cough suppressant

    Expectorant

  • INDICATIONS & USAGE

    Uses

    • temporarily relieves:

    • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants

    • the intensity of coughing

    • the impulse to cough to help your child get to sleep

    • minor aches and pains associated with:

    • the common cold • fever • sore throat

    • headache • body pain

    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of

    bothersome mucus and make coughs more productive

  • 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.

    • in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for

    depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping

    the MAOI drug. If you do not know if your child’s prescription drug contains an MAOI, ask a doctor or

    pharmacist before giving this product.

    Ask a doctor before use if the child has

    • Liver disease

    • cough that occurs with too much phlegm (mucus)

    • persistent or chronic cough such as occurs with asthma or if cough is accompanied by excessive phlegm

    (mucus) unless directed by a doctor.

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

    When using this product do not use more than directed

    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

    • cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or

    persistent headache.

    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

    • do not give more than 5 times in 24 hours

    children 6 to under 12 years10 mL every 4 hours
    children 4 to under 6 years7.5 mL every 4 hours
    children under 4 yearsdo not use

  • 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, natural flavor, purified water

  • QUESTIONS

    Questions?

    1-855-436-3921

  • SPL UNCLASSIFIED SECTION

    SHAKE WELL before each use.

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

    Distributed by: Genexa Inc., Atlanta, GA 30324

    genexa.com | U.S. Patent No. 11,617,795

  • SPL UNCLASSIFIED SECTION

    Made in the USA with globally sourced ingredients

    NDC 69676-0087-9

  • PRINCIPAL DISPLAY PANEL

    Genexa®

    MEDICINE MADE CLEAN

    Ages 4+

    Kids' Multi-Symptom Cold & Flu

    Acetaminophen 320 mg - Pain Reliever/Fever Reducer

    Dextromethorphan HBr 5mg - Cough Suppressant

    Guaifenesin 100 mg - Expectorant

    Cough

    Mucus

    Chest Congestion

    Sore Throat

    Fever

    Body Pain

    Medicine made clean

    Same effective active ingredients, but no artificial fillers.

    Organic Blueberry Flavor

    4 FL OZ (118 mL) Liquid

    Dosing cup included

    Kids Multi-Symptom Cold and Flu

  • INGREDIENTS AND APPEARANCE
    MULTI-SYMPTOM COLD AND FLU-KIDS 
    acetaminophen 320 mg, dextromethorphan hbr 5 mg, guaifenesin 100 mg suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69676-0087
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 10 mL
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN320 mg  in 10 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRUS FRUIT (UNII: XDK00Z8012)  
    AGAVE TEQUILANA JUICE (UNII: GVG8G0207O)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorbrown (Gold) Score    
    ShapeSize
    FlavorBLUEBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69676-0087-91 in 1 CARTON08/15/2023
    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 DrugM01308/15/2023
    Labeler - Genexa Inc. (079751024)