Other
Drug Facts
Other information
● each chewable tablet contains: calcium 400 mg
● store at room temperature. Avoid humidity.
● close cap tightly after use
Alka-seltzer Ultra Strength Heartburn Reliefchews Tablet, Chewable
FDA Label NDC 0280-0245
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 0280-0245). 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 - do not use, otc - ask doctor/pharmacist, otc - when using, 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
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
● do not take more than 5 chewable tablets in a 24-hour period
● do not use the maximum dosage of this product for more than 2 weeks except under the advice and supervision of a physician
● constipation may occur
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
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 1 or 2 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
Inactive Ingredient
Inactive ingredients acacia, annatto extract, ascorbyl palmitate, beta carotene, carnauba wax, citric acid, confectioners sugar, corn syrup, disodium EDTA, dl-alpha-Tocopherol, FD&C Red #40 aluminum lake, FD&C Yellow #6 aluminum lake, flavors, hydrogenated coconut oil, lecithin, maltodextrin, methylparaben, modified starch, potassium hydroxide, potassium sorbate, propylene glycol, propylparaben, shellac, silicon dioxide, sodium ascorbate, sorbic acid, sorbitol, sugar, titanium dioxide, turmeric oleoresin, vegetable oil, water, white wax
Otc - Questions
Questions or comments?
1-800-986-0369 (Mon – Fri 9AM – 5PM EST)
Package Label 50 Count
tropical twist
Alka-Seltzer®
Calcium Carbonate/Antacid
ULTRA STRENGTH
HEARTBURN
RELIEFCHEWS®
FAST POWERFUL RELIEF
50 CHEWABLE TABLETS
Label 50 Count (C6408 50ct Lbl)
* Please review the disclaimer below.
