Alka-seltzer Ultra Strength Heartburn Reliefchews Strawberry & Orange Creme Ui 1614243 & 1614244

Alka-seltzer Ultra Strength Heartburn Reliefchews Strawberry & Orange Creme Ui 1614243 & 1614244
SPL v6
SPL
SPL Set ID 84771ac5-ad0b-e0ec-e053-2a91aa0a1b36
Route
ORAL
Published
Effective Date 2019-03-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Calcium Cation (1000 mg)
Inactive Ingredients
Acacia Corn Syrup Food Yellow 3 Free Acid Maltodextrin Methylparaben Shellac Sorbic Acid White Wax Titanium Dioxide Hydrogenated Coconut Oil Water Sodium Benzoate Sucrose Carnauba Wax Fd&c Blue No. 1--aluminum Lake Medium-chain Triglycerides Propylparaben Phosphoric Acid Propylene Glycol Sorbitol

Identifiers & Packaging

Pill Appearance
Imprint: U2 Shape: round Color: red Color: orange Size: 19 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-03-03

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

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

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 take more than 5 chewable tablets in a 24-hour

period

● if pregnant do not take more than 5 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 51727-6

Inactive ingredients acacia, carnauba wax, citric acid, corn syrup, dextrin, FD&C Blue #1 aluminum lake, FD&C Red #40 aluminum lake, FD&C Yellow #6, FD&C Yellow #6 aluminum lake, flavors, hydrogenated coconut oil, lecithin, maltodextrin, medium-chain triglycerides, methylparaben, phosphoric acid, polyvinylpyrrolidone, propylene glycol, propylparaben, purified water, shellac, sodium benzoate, sorbic acid, sorbitol, sucrose, titanium dioxide, vegetable oil, white wax

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 1000 mg

Section 60561-8

Other information

each chewable tablet contains: calcium 400 mg

● store at room temperature. Avoid excessive heat above 40°C

(104°F).

● close cap tightly after use

Directions

Directions

● adults and children 12 years and over: fully chew then swallow 2 to 3 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

Questions Or Comments

Questions or comments? 1-800-986-0369

(Mon – Fri 9AM – 5PM EST)

50 Tablet Bottle Label

NEW!

Delicious

Creme

Flavors

Starts Neutralizing Acid

in Seconds!

Alka-Seltzer®

Calcium Carbonate/Antacid

ULTRA STRENGTH

HEARTBURN

RELIEFCHEWS®

Strawberry &

Orange Creme

50 CHEWABLE TABELTS


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

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

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 take more than 5 chewable tablets in a 24-hour

period

● if pregnant do not take more than 5 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 51727-6 (51727-6)

Inactive ingredients acacia, carnauba wax, citric acid, corn syrup, dextrin, FD&C Blue #1 aluminum lake, FD&C Red #40 aluminum lake, FD&C Yellow #6, FD&C Yellow #6 aluminum lake, flavors, hydrogenated coconut oil, lecithin, maltodextrin, medium-chain triglycerides, methylparaben, phosphoric acid, polyvinylpyrrolidone, propylene glycol, propylparaben, purified water, shellac, sodium benzoate, sorbic acid, sorbitol, sucrose, titanium dioxide, vegetable oil, white wax

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 1000 mg

Section 60561-8 (60561-8)

Other information

each chewable tablet contains: calcium 400 mg

● store at room temperature. Avoid excessive heat above 40°C

(104°F).

● close cap tightly after use

Directions

Directions

● adults and children 12 years and over: fully chew then swallow 2 to 3 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

Questions Or Comments (Questions or comments)

Questions or comments? 1-800-986-0369

(Mon – Fri 9AM – 5PM EST)

50 Tablet Bottle Label (50 Tablet bottle label)

NEW!

Delicious

Creme

Flavors

Starts Neutralizing Acid

in Seconds!

Alka-Seltzer®

Calcium Carbonate/Antacid

ULTRA STRENGTH

HEARTBURN

RELIEFCHEWS®

Strawberry &

Orange Creme

50 CHEWABLE TABELTS


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)