Alka-seltzer Kids Tummy Reliefchews Ui 1611515

Alka-seltzer Kids Tummy Reliefchews Ui 1611515
SPL v5
SPL
SPL Set ID ba48966e-3762-5fdf-e053-2995a90aeb3d
Route
ORAL
Published
Effective Date 2021-03-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Calcium Cation (750 mg) Dimethicone (80 mg)
Inactive Ingredients
Titanium Dioxide Triacetin Sorbitol Modified Corn Starch (1-octenyl Succinic Anhydride) Water White Wax Shellac Acacia Corn Syrup Maltodextrin Methylparaben Carnauba Wax Potassium Hydroxide Fd&c Red No. 40 Hydrogenated Coconut Oil Propylparaben Sorbic Acid

Identifiers & Packaging

Pill Appearance
Imprint: HG Shape: round Color: pink Size: 18 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-03-01

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses for the relief of:

● acid indigestion ● heartburn ● sour stomach

● upset stomach associated with these symptoms

● bloating, pressure, or stuffed feeling commonly referred to as gas

Dosage and Administration

Directions

adults and children 12 years and over • fully chew then swallow 1 or 2 chewable tablets as symptoms occur, or as directed by a doctor.

• do not take more than 6 chewable tablets in a 24-hour period
children 6 years to under 12 years • under adult supervision, fully chew then swallow 1 chewable tablet as symptoms occur, or as directed by a doctor.

• do not take more than 4 chewable tablets in a 24-hour period
children under 6 years consult a doctor

  • if pregnant, do not take more than 6 chewable tablets in 24 hours

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50567-7

When using this product

● adults and children 12 years and over do not take more than 6 chewable tablets in a 24-hour period

● children 6 to under 12 years do not take more than 4 chewable tablets in a 24-hour period

● if pregnant, do not take more than 6 chewable 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 acacia, carmine, carnauba wax, citric acid, corn starch, corn syrup, FD&C red No.40 aluminum lake, flavors, hydrogenated coconut oil, hydrogenated vegetable oil, lecithin, maltodextrin, modified starch, potassium hydroxide, pregelatinized modified starch, propylene glycol, shellac, sodium benzoate, sorbic acid, sorbitol, sucrose, titanium dioxide, triacetin, water, white wax

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 60561-8

Other information

● each chewable tablet contains: calcium 300 mg

● store at room temperature. Avoid excessive heat above 40°C (104°F).

● close cap tightly after use

Package Label 28 Count

Works

Amazingly

Fast!

Alka-Seltzer® Kids

Tummy ReliefChews®

Calcium Carbonate/Antiacid

Simethicone/Antigas

•6 Symptom Relief•

•Upset Stomach

•Gas • Bloating

•Acid Indigestion

•Heartburn

•Upset Stomach

FRUIT PUNCH

28 CHEWABLE TABLETS

Active Ingredients and Purpoose

Active ingredients (in each chewable tablet) Purpose

Calcium carbonate 750 mg….................................….…...Antacid

Simethicone 80 mg……………………………………….......Antigas


Structured Label Content

Indications and Usage (34067-9)

Uses for the relief of:

● acid indigestion ● heartburn ● sour stomach

● upset stomach associated with these symptoms

● bloating, pressure, or stuffed feeling commonly referred to as gas

Dosage and Administration (34068-7)

Directions

adults and children 12 years and over • fully chew then swallow 1 or 2 chewable tablets as symptoms occur, or as directed by a doctor.

• do not take more than 6 chewable tablets in a 24-hour period
children 6 years to under 12 years • under adult supervision, fully chew then swallow 1 chewable tablet as symptoms occur, or as directed by a doctor.

• do not take more than 4 chewable tablets in a 24-hour period
children under 6 years consult a doctor

  • if pregnant, do not take more than 6 chewable tablets in 24 hours

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

● adults and children 12 years and over do not take more than 6 chewable tablets in a 24-hour period

● children 6 to under 12 years do not take more than 4 chewable tablets in a 24-hour period

● if pregnant, do not take more than 6 chewable 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 acacia, carmine, carnauba wax, citric acid, corn starch, corn syrup, FD&C red No.40 aluminum lake, flavors, hydrogenated coconut oil, hydrogenated vegetable oil, lecithin, maltodextrin, modified starch, potassium hydroxide, pregelatinized modified starch, propylene glycol, shellac, sodium benzoate, sorbic acid, sorbitol, sucrose, titanium dioxide, triacetin, water, white wax

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 60561-8 (60561-8)

Other information

● each chewable tablet contains: calcium 300 mg

● store at room temperature. Avoid excessive heat above 40°C (104°F).

● close cap tightly after use

Package Label 28 Count (Package label 28 count)

Works

Amazingly

Fast!

Alka-Seltzer® Kids

Tummy ReliefChews®

Calcium Carbonate/Antiacid

Simethicone/Antigas

•6 Symptom Relief•

•Upset Stomach

•Gas • Bloating

•Acid Indigestion

•Heartburn

•Upset Stomach

FRUIT PUNCH

28 CHEWABLE TABLETS

Active Ingredients and Purpoose (Active ingredients and purpoose)

Active ingredients (in each chewable tablet) Purpose

Calcium carbonate 750 mg….................................….…...Antacid

Simethicone 80 mg……………………………………….......Antigas


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)