FDA Label for Genexa Childrens Acetaminophen
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 - WHEN USING
- OTC - STOP USE
- OTC - KEEP OUT OF REACH OF CHILDREN
- OVERDOSAGE
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Genexa Childrens Acetaminophen 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
Carton and bottle are safety sealed. DO NOT use if seal on top and/or bottom of carton or under cap of bottle is disturbed or missing.
*This product is not manufactured or distributed by Johnson & Johnson Inc., owner of the registered trademark Children's Tylenol® Chewables Grape.
Patent Pending | Distributed by: Genexa Inc.
Atlanta, GA 30318 | genexa.com
Made in the USA with globally sourced ingredients
R-20211230
NDC 69676-0058-7
Otc - Active Ingredient
Active ingredient (in each tablet)
Acetaminophen 80 mg
Otc - Purpose
Purpose
Pain reliever/fever reducer
Indications & Usage
Uses
- temporarily relieves minor aches and pains due to:
- the common cold
- sore throat
- flu
- toothache
- headache
- temporarily reduces fever
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.
- if your child is allergic to acetaminophen or any of the inactive ingredients in this product
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.
Overdosage
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 for adults as well as for children 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)
- find right dose on chart below. If possible, use weight to dose; otherwise, use age.
- chew tablets completely before swallowing; do not swallow tablets whole
- repeat dose every 4 hours while symptoms last
- 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 | 2 tablets |
36-47 lbs. | 4-5 years | 3 tablets |
48-59 lbs. | 6-8 years | 4 tablets |
60-71 lbs. | 9-10 years | 5 tablets |
72-95 lbs. | 11 years | 6 tablets |
†or as directed by a doctor
Other Safety Information
Other information
- each tablet contains: calcium 20 mg
- store between 20-25°C (68-77°F). Avoid high humidity. Protect from light.
Inactive Ingredient
Inactive ingredients
acacia gum, agave fiber, agave syrup, calcium carbonate, organic carnauba wax, citric acid, dextrose, flavor, natural grape flavor, guar gum, maltodextrin, rice hulls, organic stevia rebaudiana leaf extract, xylitol
Otc - Questions
Questions? 1-855-436-3921
Package Label.Principal Display Panel
Children's
Genexa®
MEDICINE MADE CLEAN
Ages 2-11
Acetaminophen
Pain Reliever Fever Reducer
How we're different
Made without: crospovidone, D&C red no. 30 aluminum lake, sucralose & more!
Read our label vs. Children'sTylenol® Chewables Grape*
24 Chewable Tablets
80 mg each
Grape Flavor
* Please review the disclaimer below.