CHILDRENS ACETAMINOPHEN ORAL SUSPENSION- acetaminophen suspension

Childrens Acetaminophen Oral Suspension by

Drug Labeling and Warnings

Childrens Acetaminophen Oral Suspension by is a Otc medication manufactured, distributed, or labeled by Genexa Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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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

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

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
24-35lbs.	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

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

QUESTIONS

Questions?1-855-436-3921

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*This product is not manufactured or distributed by Johnson & Johnson Corp., owner of the registered trademark Children's Tylenol® Oral Suspension Grape.

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Give it a SHAKE! We use clean ingredients so it's normal for them to separate and change color over time.

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

Certified B Corporation

CERTIFIED GLUTEN FREE GFCO.ORG

CERTIFIED VEGAN VEGAN.ORG

Patent Pending | Distributed by: Genexa Inc.

Atlanta, GA 30318 | genexa.com

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Made in the USA with globally sourced ingredients

NDC: 69676-0069-9

PRINCIPAL DISPLAY PANEL

Children's

Genexa®

MEDICINE MADE CLEAN

Ages 2-11

Acetaminophen

160 mg per 5 mL | Oral Suspension

Pain Reliever Fever Reducer

Compare to active ingredient in Children's Tylenol® Oral Suspension Grape

How we're different

Made without: high fructose corn syrup, FD&C blue no. 1, D&C red no. 33 & more!

Organic Blueberry Flavor

Ibuprofen Free, Aspirin Free

4 fl oz (118 mL) Dosing cup included

INGREDIENTS AND APPEARANCE

CHILDRENS ACETAMINOPHEN ORAL SUSPENSION 
acetaminophen suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69676-0069
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
WATER (UNII: 059QF0KO0R)
CITRUS FRUIT (UNII: XDK00Z8012)
BLUEBERRY (UNII: 253RUG1X1A)
AGAVE TEQUILANA JUICE (UNII: GVG8G0207O)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69676-0069-9	1 in 1 CARTON	05/10/2022
1		118 mL in 1 BOTTLE, PLASTIC; 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	05/10/2022

Labeler - Genexa Inc. (079751024)