Spl Indexing Data Elements
Drug Facts
Alka-seltzer Cool Action Extra Strength Reliefchews Mint Tablet, Chewable
FDA Label NDC 0280-0058
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 Extra Strength Reliefchews Mint (NDC 0280-0058). 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 spl indexing data elements, 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 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/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 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 4 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 Information
Other information
● each chewable tablet contains: calcium 300 mg
● store at room temperature. Avoid excessive heat above 40°C (104°F).
● avoid excessive humidity
● close cap tightly after use
Inactive Ingredient
Inactive ingredients carnauba wax, citric acid, coconut oil, corn syrup, dextrin, FD&C Blue No.1, FD&C Blue No.1 Aluminum Lake, FD&C Red No.40 Aluminum Lake, FD&C Yellow No.6 Aluminum Lake, flavors, glycerin, gum arabic, lecithin, maltodextrin, mono and diglycerides, potassium sorbate, propylene glycol, purified water, shellac, sorbic acid, sucrose, titanium dioxide, vegetable oil, white wax, xylitol
Questions Or Comments
Questions or comments? 1-800-986-0369
(Mon – Fri 9AM – 5PM EST)
Bottle Label 30 Tablets
Starts Neutralizing Acid
in Seconds!
NEW
Cooling
Sensation
Alka-Seltzer®
Calcium Carbonate/Antacid
EXTRA STRENGTH
COOL ACTION
HEARTBURN
RELIEFCHEWS®
cool mint
30 Chewable Tablets
As Cool Action Relief Chews Mint Bottle Label (C7863 As 30ct Wrap Lbl R Page 1)
* Please review the disclaimer below.
