GENEXA INFANTS PAIN AND FEVER- acetaminophen suspension

Genexa Infants Pain and Fever by

Drug Labeling and Warnings

Genexa Infants Pain and Fever by is a Otc medication manufactured, distributed, or labeled by Genexa Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Keep outer package for complete product information

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each 5 mL)

Acetaminophen 160 mg

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.

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.

Ask a doctor before use if your child has liver disease

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

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

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.

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

Drug Facts (continued)

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 the 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, natural flavor, purified water

QUESTIONS

Questions?1-855-436-3921

SPL UNCLASSIFIED SECTION

Bottle is safety sealed with a perforated band around bottle. DO NOT use if bottle seal is disturbed or missing.

Certified B Corporation

Certified Gluten-Free

CERTIFIED VEGAN

Distributed by: Genexa Inc. | Atlanta, GA 30324

genexa.com | U.S Patent No. 11,617,795

SPL UNCLASSIFIED SECTION

Made in the USA with globally sourced ingredients

NDC: 69676-0042-9

PRINCIPAL DISPLAY PANEL

Genexa®

MEDICINE MADE CLEAN

Infants' Pain & Fever

Acetaminophen

160 mg per 5 mL* | Oral Suspension

Pain Reliever - Fever Reducer

Medicine made clean

Same effective active ingredient, but no artificial fillers.

Organic Blueberry Flavor

2 fl oz (59 mL)

Use Only Enclosed Syringe

*Same as Genexa Kids' Pain & Fever

INGREDIENTS AND APPEARANCE

GENEXA INFANTS PAIN AND FEVER 
acetaminophen suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69676-0042
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	160 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
BLUEBERRY (UNII: 253RUG1X1A)
AGAVE TEQUILANA JUICE (UNII: GVG8G0207O)
WATER (UNII: 059QF0KO0R)
CITRUS FRUIT (UNII: XDK00Z8012)

Product Characteristics
Color	brown (Light brown)	Score
Shape		Size
Flavor	BLUEBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69676-0042-9	1 in 1 CARTON	12/29/2023
1		59 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	12/29/2023

Labeler - Genexa Inc. (079751024)