FDA Label for Kids Multi Symptom Cold And Flu

Other

Drug Facts

SHAKE WELL before each use.

Tamper evident: Do not use if perforated band around the bottle 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 69676-0096-9

Otc - Active Ingredient

Active ingredients

(in each 10 mL)

Acetaminophen 320 mg

Dextromethorphan HBr, USP 5 mg

Otc - Purpose

Purposes

Pain reliever/fever reducer

Cough suppressant

Indications & Usage

Uses

• temporarily reduces fever and relieves these common cold/flu symptoms:
• minor aches & pains
• headache
• cough due to minor throat and bronchial irritation
• sore throat
• controls the impulse to cough to help your child get to sleep

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 - Do Not Use

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.

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).

Otc - Ask Doctor/Pharmacist

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

Otc - When Using

When using this product do not use more than directed

Otc - Stop Use

Stop use and ask a doctor if

• pain or cough 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 comes back or occurs with rash or headache that lasts.

These could be signs of a serious condition.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Overdosage

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 each use
• 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 years	10 mL every 4 hours
children 4 to under 6 years	7.5 mL every 4 hours
children under 4 years	do not use

Storage And Handling

Other information

• store between 20-25°C (68-77°F)
• do not refrigerate

Inactive Ingredient

Inactive ingredients

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

Otc - Questions

Questions? 1-855-436-3921

Package Label.Principal Display Panel

NEW FORMULA!

Genexa®

MEDICINE MADE CLEAN

Ages 4+

Kids' Multi-Symptom Cold & Flu

Acetaminophen 320 mg - Pain Reliever/Fever Reducer

Dextromethorphan HBr 5 mg - Cough Suppressant

Fever

Headache

Body Aches & Pains

Sore Throat

Cough

Medicine made clean

Same effective active ingredients, but no artificial fillers.

Organic Blueberry Flavor

4 fl oz (118 mL) Dosing cup included