Alka-seltzer Cool Action Extra Strength Heartburn Reliefchews - Mint Ui 1614266

Alka-seltzer Cool Action Extra Strength Heartburn Reliefchews - Mint Ui 1614266
SPL v6
SPL
SPL Set ID 849bd52a-b730-3ba7-e053-2a91aa0a507c
Route
ORAL
Published
Effective Date 2019-03-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Calcium Cation (750 mg)
Inactive Ingredients
Glycerin Water Corn Syrup Propylene Glycol Shellac White Wax Fd&c Blue No. 1 Fd&c Blue No. 1--aluminum Lake Maltodextrin Titanium Dioxide Sucrose Sorbic Acid Xylitol Potassium Sorbate Carnauba Wax Coconut Oil

Identifiers & Packaging

Pill Appearance
Imprint: AS Shape: round Color: blue Size: 18 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-03-03

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

Description

Drug Facts

Uses

Uses for the relief of:

● acid indigestion ● heartburn ● sour stomach

● upset stomach associated with these symptoms

Section 48779-3

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50567-7

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

Section 50568-5

Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.

Section 50570-1

Do not use if you have ever had an allergic reaction to this product or any of its ingredients

Section 51727-6

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

Section 53414-9

If pregnant or breast-feeding, inform your doctor that you are using this product.

Section 55105-1

Purpose

Antacid

Section 55106-9

Active ingredient (in each chewable tablet)

Calcium carbonate 750 mg

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 40ºC (104ºF).

● avoid excessive humidity

● close cap tightly after use

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


Structured Label Content

Uses

Uses for the relief of:

● acid indigestion ● heartburn ● sour stomach

● upset stomach associated with these symptoms

Warnings and Precautions (34071-1)

Warnings

Section 48779-3 (48779-3)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50567-7 (50567-7)

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

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.

Section 50570-1 (50570-1)

Do not use if you have ever had an allergic reaction to this product or any of its ingredients

Section 51727-6 (51727-6)

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

Section 53414-9 (53414-9)

If pregnant or breast-feeding, inform your doctor that you are using this product.

Section 55105-1 (55105-1)

Purpose

Antacid

Section 55106-9 (55106-9)

Active ingredient (in each chewable tablet)

Calcium carbonate 750 mg

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)

Other information

● each chewable tablet contains: calcium 300 mg

● store at room temperature. Avoid excessive heat above 40ºC (104ºF).

● avoid excessive humidity

● close cap tightly after use

Questions Or Comments (Questions or comments)

Questions or comments? 1-800-986-0369

(Mon – Fri 9AM – 5PM EST)

Bottle Label 30 Tablets (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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)