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Drug Facts
Alka-seltzer Kids Tummy Reliefchews Tablet, Chewable
FDA Label NDC 0280-0051
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bayer Healthcare Llc. for the product Alka-seltzer Kids Tummy Reliefchews (NDC 0280-0051). 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, active ingredients and purpoose, indications & usage, warnings, otc - do not use, otc - ask doctor/pharmacist, otc - when using, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients And Purpoose
Active ingredients (in each chewable tablet) Purpose
Calcium carbonate 750 mg….................................….…...Antacid
Simethicone 80 mg……………………………………….......Antigas
Indications & Usage
Uses for the relief of:
● acid indigestion ● heartburn ● sour stomach
● upset stomach associated with these symptoms
● bloating, pressure, or stuffed feeling commonly referred to as gas
Warnings
Warnings
Otc - Do Not Use
Do not use if you have ever had an allergic reaction to this product or any of its ingredients
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.
Otc - When Using
When using this product
● adults and children 12 years and over do not take more than 6 chewable tablets in a 24-hour period
● children 6 to under 12 years do not take more than 4 chewable tablets in a 24-hour period
● if pregnant, do not take more than 6 chewable tablets in 24 hours
● do not use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a
physician
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, inform your doctor that you are using this product.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Dosage & Administration
Directions
| adults and children 12 years and over | • fully chew then swallow 1 or 2 chewable tablets as symptoms occur, or as directed by a doctor.
• do not take more than 6 chewable tablets in a 24-hour period |
| children 6 years to under 12 years | • under adult supervision, fully chew then swallow 1 chewable tablet as symptoms occur, or as directed by a doctor.
• do not take more than 4 chewable tablets in a 24-hour period |
| children under 6 years | consult a doctor |
- if pregnant, do not take more than 6 chewable tablets in 24 hours
Other Safety Information
Other information
● each chewable tablet contains: calcium 300 mg
● store at room temperature. Avoid excessive heat above 40°C (104°F).
● close cap tightly after use
Inactive Ingredient
Inactive ingredients acacia, carmine, carnauba wax, citric acid, corn starch, corn syrup, FD&C red No.40 aluminum lake, flavors, hydrogenated coconut oil, hydrogenated vegetable oil, lecithin, maltodextrin, modified starch, potassium hydroxide, pregelatinized modified starch, propylene glycol, shellac, sodium benzoate, sorbic acid, sorbitol, sucrose, titanium dioxide, triacetin, water, white wax
Otc - Questions
Questions or comments? 1-800-986-0369 (Mon – Fri 9AM – 5PM EST)
Package Label 28 Count
Works
Amazingly
Fast!
Alka-Seltzer® Kids
Tummy ReliefChews®
Calcium Carbonate/Antiacid
Simethicone/Antigas
•6 Symptom Relief•
•Upset Stomach
•Gas • Bloating
•Acid Indigestion
•Heartburn
•Upset Stomach
FRUIT PUNCH
28 CHEWABLE TABLETS
* Please review the disclaimer below.
