Childrens Tummy Relief Tablet, Chewable
FDA Label NDC 69676-0060

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Genexa Inc. for the product Childrens Tummy Relief (NDC 69676-0060). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - ask doctor/pharmacist, otc - when using, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.

Inactive Ingredient

Inactive ingredients

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

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