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  5. Label Information: Multi-symptom Cold And Flu-kids

FDA Label for Multi-symptom Cold And Flu-kids

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - ACTIVE INGREDIENT
    3. OTC - PURPOSE
    4. INDICATIONS & USAGE
    5. WARNINGS
    6. OTC - DO NOT USE
    7. OTC - ASK DOCTOR
    8. OTC - ASK DOCTOR/PHARMACIST
    9. OTC - WHEN USING
    10. OTC - STOP USE
    11. OTC - KEEP OUT OF REACH OF CHILDREN
    12. OVERDOSAGE
    13. DOSAGE & ADMINISTRATION
    14. STORAGE AND HANDLING
    15. INACTIVE INGREDIENT
    16. OTC - QUESTIONS
    17. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Multi-symptom Cold And Flu-kids Product Label

The following document was submitted to the FDA by the labeler of this product Genexa Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts

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

Made in the USA with globally sourced ingredients

NDC 69676-0087-9


Otc - Active Ingredient



Active ingredients (in each 10 mL)

Acetaminophen 320 mg

Dextromethorphan HBr, USP 5 mg

Guaifenesin, USP 100 mg


Otc - 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.


Otc - Ask Doctor



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.


Otc - Ask Doctor/Pharmacist



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


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


* Please review the disclaimer below.