Multi-symptom Cold And Flu-kids
FDA Label NDC 69676-0087

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Genexa Inc. for the product Multi-symptom Cold And Flu-kids (NDC 69676-0087). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.