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Drug Facts
Alka-seltzer Cool Action Heartburn Relief Gum, Chewing
FDA Label NDC 0280-0001
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 Cool Action Heartburn Relief (NDC 0280-0001). 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, 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 chewing piece)
Calcium carbonate 750 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
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 use more than 5 pieces in a 24-hour period
● if pregnant do not use more than 5 pieces 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
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: chew 1 - 2 pieces as symptoms occur or as directed by a doctor
● children under 12 years: consult a doctor
● do not use more than 5 pieces in a 24-hour period
● if pregnant, do not use more than 5 pieces in 24-hour period
● do not swallow the gum
Other Safety Information
Other information
● each piece contains: calcium 300 mg
● store at room temperature. Avoid humidity and excessive heat above 40°C (104°F).
Inactive Ingredient
Inactive ingredients acesulfame potassium, butylated hydroxytoluene, copovidone, FD&C Blue No.1 Aluminum Lake, flavors, gum base, isomalt, magnesium stearate, sorbitol, sucralose, talc, titanium dioxide
Otc - Questions
Questions or comments? 1-800-986-0369
(Mon – Fri 9AM – 5PM EST)
Carton Count 16 Pieces
Works Fast!
Alka-Seltzer®
Calcium Carbonate/
Antacid
EXTRA STRENGTH
COOL ACTION
HEARTBURN RELIEF
GUM
cool mint
16 pieces
* Please review the disclaimer below.
