Active Ingredient (In Each Chewable Tablet)
Calcium carbonate 750 mg
Alka-seltzer Extra Strength Heartburn Reliefchews Tablet, Chewable
FDA Label NDC 0280-0042
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 Extra Strength Heartburn Reliefchews (NDC 0280-0042). 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 active ingredient (in each chewable tablet), purpose, uses, do not use if, ask a doctor or pharmacist before use if you are, when using this product, if pregnant or breast-feeding, 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
Purpose
Antacid
Uses
for the relief of:
- acid indigestion
- heartburn
- sour stomach
- upset stomach associated with these symptoms
Do Not Use If
you have ever had an allergic reaction to this product or any of its ingredients
Ask A Doctor Or Pharmacist Before Use If You Are
presently taking a prescription drug. Antacids may interact with certain prescription drugs.
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
If Pregnant Or Breast-Feeding
If pregnant or breast-feeding, ask a health professional before use.
Keep Out Of Reach Of Children
Keep out of reach of children.
Directions
- adults and children 12 years and over: fully chew then swallow 1 or 2 chewable tablets as symptoms occur, or as directed by as doctor
- children under 12 years: consult a doctor
- do not take more than 5 chewable tablets in a 24-hour period
Other Information
- each chewable tablet contains: calcium 300 mg
- contains FD&C Yellow No. 5 (tartrazine) as a color additive
- store at room temperature. Avoid humidity.
- close cap tightly after use
Inactive Ingredients
acacia, carmine, carnauba wax, citric acid, corn starch, corn syrup, DL-alpha tocopherol, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #5 lake (tartrazine), FD&C yellow #6, FD&C yellow #6 aluminum lake, FD&C yellow #6 lake, flavors, hydrogenated coconut oil, hydrogenated vegetable oil, lecithin, medium chain triglycerides, methyl paraben, modified starch, phosphoric acid, pregelatinized modified starch, propyl paraben, propylene glycol, shellac, sodium benzoate, sorbic acid, sorbitol, sugar, titanium dioxide, water, white wax
Questions Or Comments?
Questions or comments?
1-800-986-0369 (Mon-Fri 9AM - 5PM EST)
Principle Display Panel
assorted fruit
Alka-Seltzer
Calcium Carbonate / Antacid
Extra Strength
Heartburn ReliefChews
Fast
Powerful
relief
Bayer
60 CHEWABLE TABLETS
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