CHILDRENS TUMMY RELIEF- calcium carbonate tablet, chewable

Childrens Tummy Relief by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each tablet)

Calcium carbonate USP 400 mg

PURPOSE

Purpose

Antacid

INDICATIONS & USAGE

Uses

relieves

• heartburn
• acid indigestion
• sour stomach
• upset stomach associated with these symptoms

WARNINGS

Warnings

Ask a doctor or pharmacist before use if the child is presently taking a prescription drug. Antacids may interact with certain prescription drugs.

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

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

SPL UNCLASSIFIED SECTION

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

INACTIVE INGREDIENT

Inactive ingredients

organic beet root, organic carnauba wax, dextose, organic flavors, organic maltodextrin, organic rice bran extract

QUESTIONS

Questions?

1-855-436-3921

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

Made in the USA with globally sourced ingredients

R-20220321

NDC: 69676-0060-7

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

INGREDIENTS AND APPEARANCE

CHILDRENS TUMMY RELIEF 
calcium carbonate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69676-0060
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D, CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CARBONATE	400 mg

Inactive Ingredients
Ingredient Name	Strength
BEET (UNII: N487KM8COK)
CARNAUBA WAX (UNII: R12CBM0EIZ)
DEXTROSE (UNII: IY9XDZ35W2)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
RICE BRAN (UNII: R60QEP13IC)

Product Characteristics
Color	pink (Tan)	Score	no score
Shape	ROUND	Size	13mm
Flavor	VANILLA, BERRY	Imprint Code	G;strawberry
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69676-0060-7	1 in 1 CARTON	10/21/2022
1		30 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 final	part331	10/21/2022

Labeler - Genexa Inc. (079751024)