FDA Label for Kids Pain And Fever

Other

Drug Facts

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.

Bottle is safety sealed. DO NOT use if bottle seal is disturbed or missing.

Patent Pending | Distributed by: Genexa Inc.

Los Angeles, CA 90034 | genexa.com

Made in the USA with globally sourced ingredients

NDC 69676-0041-9

Otc - Active Ingredient

Active ingredient (in each 5 mL)

Acetaminophen 160 mg

Otc - 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.

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.

Otc - Ask Doctor

Ask a doctor before use if your child has liver disease

Otc - Ask Doctor/Pharmacist

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

Otc - Stop Use

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.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

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

Weight	Age	Dose
under 24 lbs.	under 2 years	ask a doctor
24-35 lbs.	2-3 years	5 mL
36-47 lbs.	4-5 years	7.5 mL
48-59 lbs.	6-8 years	10 mL
60-71 lbs.	9-10 years	12.5 mL
72-95 lbs.	11 years	15 mL

Storage And Handling

Other information

store between 20-25°C (68-77°F)

Inactive Ingredient

Inactive ingredients oganic agave syrup, organic blueberry flavor, natural citrus extract, non-GMO flavor, purified water

Otc - Questions

Questions?

1-855-436-3921 Mon.-Fri. 7am - 6pm PST

Package Label.Principal Display Panel

Genexa

REAL MEDICINE MADE CLEAN

Kids' Pain & Fever

Pain Fever

Acetaminophen 160 mg per 5 mL
Pain Reliever-Fever Reducer

Flavored with Organic Blueberries

No allergens, dyes, or parabens

Ages 2+ Dosing cup included

4 FL OZ (118 mL) Liquid