FDA Label for Genexa Infants Pain And Fever

Other

Keep outer package for complete product information

Drug Facts

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

Certified B Corporation

Certified Gluten-Free

CERTIFIED VEGAN

Patent Pending

Distributed by: Genexa Inc., Atlanta, GA 30318

genexa.com

Made in the USA with globally sourced ingredients

R-20210427

NDC 69676-0042-9

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 - When Using

When using this product, do not exceed recommended dose (see overdose warning)

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.

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
• mL = milliliter
• find right dose on chart below. If possible, use weight to dose; otherwise, use age
• push air out of syringe. Insert syringe tip into the bottle opening
• flip bottle upside down. Pull white part of syringe to correct dose
• dispense liquid slowly into child's mouth, toward inner cheek
• repeat dose every 4 hours while symptoms last
• do not give more than 5 times in 24 hours
• replace cap tightly to maintain child-resistant packaging

Attention: use only enclosed syringe specifically designed for use with this product. Do not use any other dosing device.

Weight	Age	Dose
under 24 lbs.	under 2 years	ask a doctor
24-35 lbs.	2-3 years	5 mL

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, non-GMO flavor, purified water

Otc - Questions

Questions?1-855-436-3921

Package Label.Principal Display Panel

Genexa

REAL MEDICINE MADE CLEAN

Infants' Pain & Fever

Pain

Fever

Acetaminophen 160 mg per 5 mL

Oral Suspension

Pain Reliever - Fever Reducer

Made with Organic Blueberry Flavor

No common allergens, artificial dyes, or parabens

Ages 2-3 years

Use Only Enclosed Syringe

2 FL OZ (59 mL)