FDA Label for Alka-seltzer Cool Action Extra Strength Reliefchews Mint
View Indications, Usage & Precautions
- SPL INDEXING DATA ELEMENTS
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- USES
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS OR COMMENTS
- BOTTLE LABEL 30 TABLETS
Alka-seltzer Cool Action Extra Strength Reliefchews Mint Product Label
The following document was submitted to the FDA by the labeler of this product Bayer Healthcare Llc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Spl Indexing Data Elements
Drug Facts
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
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