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Alka-seltzer Ultra Strength Heartburn Reliefchews Tablet, Chewable
FDA Label NDC 0280-0059
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 Ultra Strength Heartburn Reliefchews (NDC 0280-0059). 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, uses, warnings, 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
Otc - Active Ingredient
Active ingredient (in each chewable tablet)
Calcium carbonate 1000 mg
Otc - Purpose
Purpose
Antacid
Uses
Uses for the relief of:
● acid indigestion ● heartburn ● sour stomach
● upset stomach associated with these symptoms
Warnings
Warnings
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
● do not take more than 5 chewable tablets in a 24-hour
period
● if pregnant do not take more than 5 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.
Directions
Directions
● adults and children 12 years and over: fully chew then swallow 2 to 3 chewable tablets as symptoms occur, or as directed by a doctor
● children under 12 years: consult a doctor
● do not take more than 5 chewable tablets in a 24-hour period
● if pregnant, do not take more than 5 chewable tablets in 24
hours
Other Safety Information
Other information
● each chewable tablet contains: calcium 400 mg
● store at room temperature. Avoid excessive heat above 40°C
(104°F).
● close cap tightly after use
Inactive Ingredient
Inactive ingredients acacia, carnauba wax, citric acid, corn syrup, dextrin, FD&C Blue #1 aluminum lake, FD&C Red #40 aluminum lake, FD&C Yellow #6, FD&C Yellow #6 aluminum lake, flavors, hydrogenated coconut oil, lecithin, maltodextrin, medium-chain triglycerides, methylparaben, phosphoric acid, polyvinylpyrrolidone, propylene glycol, propylparaben, purified water, shellac, sodium benzoate, sorbic acid, sorbitol, sucrose, titanium dioxide, vegetable oil, white wax
Questions Or Comments
Questions or comments? 1-800-986-0369
(Mon – Fri 9AM – 5PM EST)
50 Tablet Bottle Label
NEW!
Delicious
Creme
Flavors
Starts Neutralizing Acid
in Seconds!
Alka-Seltzer®
Calcium Carbonate/Antacid
ULTRA STRENGTH
HEARTBURN
RELIEFCHEWS®
Strawberry &
Orange Creme
50 CHEWABLE TABELTS
Bottle Label 50 Count (C7964 As 50ct Lbl Ra Page 1)
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