FDA Label for Childrens Acetaminophen Oral Suspension
View Indications, Usage & Precautions
- OTHER
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - STOP USE
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Childrens Acetaminophen Oral Suspension Product Label
The following document was submitted to the FDA by the labeler of this product Genexa Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
*This product is not manufactured or distributed by Johnson & Johnson Corp., owner of the registered trademark Children's Tylenol® Oral Suspension Grape.
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
Made in the USA with globally sourced ingredients
NDC 69676-0069-9
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
- skin reddening
- blisters
- rash
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
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.
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
Otc - Questions
Questions?1-855-436-3921
Package Label.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
* Please review the disclaimer below.