Label: KIDS TUMMY RELIEF- calcium carbonate tablet, chewable
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Contains inactivated NDC Code(s)
NDC Code(s): 69676-0043-7 - Packager: Genexa Inc.
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated January 6, 2022
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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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.
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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
- INACTIVE INGREDIENT
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
KIDS TUMMY RELIEF
calcium carbonate tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69676-0043 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 white (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:69676-0043-7 1 in 1 CARTON 07/23/2020 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 07/23/2020 Labeler - Genexa Inc. (079751024)