FDA Label for Childrens Tummy Relief
View Indications, Usage & Precautions
Childrens Tummy Relief 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
Other information
- each tablet contains: elemental calcium 160 mg
- store between 20-25°C (68-77°F) in a dry place out of direct sunlight
Bottle is safety sealed with a perforated band around bottle. DO NOT use if bottle seal is disturbed or missing.
Patent Pending I Distributed by:
Genexa Inc. Atlanta, GA 30318
genexa.com
Made in the USA with globally sourced ingredients
R-20220321
NDC 69676-0060-7
Otc - Active Ingredient
Active ingredient (in each tablet)
Calcium carbonate USP 400 mg
Otc - Purpose
Purpose
Antacid
Indications & Usage
Uses
relieves
- heartburn
- acid indigestion
- sour stomach
- upset stomach associated with these symptoms
Warnings
Warnings
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if the child is presently taking a prescription drug. Antacids may interact with certain prescription drugs.
Otc - When Using
When using this product
- do not give the child more than 3 tablets (ages 2-5) or 6 tablets (ages 6-11) in 24 hours
- do not give the child the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Dosage & Administration
Directions
Find right dose on chart below based on weight (preferable); otherwise use age
| Weight | Age | Dose |
| over 48 lbs. | 6-11 years | chew 2 tablets as symptoms occur, not to exceed 6 tablets in 24 hours |
| 24-47 lbs. | 2-5 years | chew 1 tablet as symptoms occur, not to exceed 3 tablets in 24 hours |
| under 24 lbs. | under 2 years | ask a doctor |
Inactive Ingredient
Inactive ingredients
organic beet root, organic carnauba wax, dextose, organic flavors, organic maltodextrin, organic rice bran extract
Otc - Questions
Questions?
1-855-436-3921
Package Label.Principal Display Panel
Children's
Genexa®
MEDICINE MADE CLEAN
Ages 2-11
Tummy Relief
Calcium Carbonate Antacid
Heartburn
Sour Stomach
Acid Indigestion
Upset Stomach
Compare to active ingredient in Pepto Bismol® Kids
Chewable Tablets Bubblegum*
How we're different
Made without: talc, D&C red no. 27 aluminum lake, sorbitol & more!
Organic Berry & Vanilla Flavor
30 Chewable Tablets
* Please review the disclaimer below.