FDA Label for Kids Tummy Relief
View Indications, Usage & Precautions
Kids 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 160mg
- store between 20-25°C (68-77°F) in a dry place out of direct sunlight
All ingredients are USDA Certified Organic, except Calcium Carbonate. Calcium Carbonate is a mineral and USDA regulations do not certify minerals. Genexa's Calcium Carbonate is Non-GMO Project Verified.
Bottle is safety sealed. DO NOT use if bottle seal is disturbed or missing.
Patent Pending I Distributed by:
Genexa Inc. Los Angeles, CA 90034
genexa.com
NDC 69676-0043-7
Made in the USA with globally sourced ingredients
NDC 69676-0043-7
Otc - Active Ingredient
Active ingredient (in each tablet)
Calcium Carbonate USP 400mg
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 your 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, organic flavors, organic rice bran extract, organic tapioca dextrose, organic tapioca maltodextrin
Otc - Questions
Questions?
1-855-436-3921 Mon.-Fri. 7am - 6pm PST
Package Label.Principal Display Panel
Genexa
REAL MEDICINE MADE CLEAN
Kids' Tummy Relief
Heartburn
Sour Stomach
Acid Indigestion
Upset Stomach
Organic Calcium Carbonate Antacid*
Flavored with Organic Berry & Vanilla
30 Chewable Tablets
Ages 2+
* Please review the disclaimer below.