Alka-seltzer Cool Action Heartburn Relief Gum (mint) Ui 1614451

Alka-seltzer Cool Action Heartburn Relief Gum (mint) Ui 1614451
SPL v7
SPL
SPL Set ID 9b8da147-8d0c-e6b0-e053-2a95a90a35e6
Route
ORAL
Published
Effective Date 2020-03-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Calcium Cation (750 mg)
Inactive Ingredients
Isomalt Sorbitol Acesulfame Titanium Dioxide Sucralose Magnesium Stearate Fd&c Blue No. 1--aluminum Lake Copovidone K25-31 Butylated Hydroxytoluene Talc

Identifiers & Packaging

Pill Appearance
Imprint: 750 Shape: round Color: blue Size: 16 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-03-01

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 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50567-7

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

Section 50569-3

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 acesulfame potassium, butylated hydroxytoluene, copovidone, FD&C Blue No.1 Aluminum Lake, flavors, gum base, isomalt, magnesium stearate, sorbitol, sucralose, talc, titanium dioxide

Section 53413-1

Questions or comments? 1-800-986-0369

(Mon – Fri 9AM – 5PM EST)

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 chewing piece)

Calcium carbonate 750 mg

Section 60561-8

Other information

each piece contains: calcium 300 mg

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

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

Carton Count 16 Pieces

Works Fast!

Alka-Seltzer®

Calcium Carbonate/

Antacid

EXTRA STRENGTH

COOL ACTION

HEARTBURN RELIEF

GUM

cool mint

16 pieces


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 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50567-7 (50567-7)

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

Section 50569-3 (50569-3)

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 acesulfame potassium, butylated hydroxytoluene, copovidone, FD&C Blue No.1 Aluminum Lake, flavors, gum base, isomalt, magnesium stearate, sorbitol, sucralose, talc, titanium dioxide

Section 53413-1 (53413-1)

Questions or comments? 1-800-986-0369

(Mon – Fri 9AM – 5PM EST)

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 chewing piece)

Calcium carbonate 750 mg

Section 60561-8 (60561-8)

Other information

each piece contains: calcium 300 mg

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

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

Carton Count 16 Pieces (Carton count 16 pieces)

Works Fast!

Alka-Seltzer®

Calcium Carbonate/

Antacid

EXTRA STRENGTH

COOL ACTION

HEARTBURN RELIEF

GUM

cool mint

16 pieces


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)