legend premium heartburn relief-extra strength chewable

legend premium heartburn relief-extra strength chewable
SPL v1
SPL
SPL Set ID 8601a194-fdf1-4a33-854e-153a7a2c578e
Route
oral
Published
Effective Date 2020-06-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
calcium cation (750 mg)
Inactive Ingredients
dextrose monohydrate saccharin sodium sucrose houttuynia cordata flowering top fd&c blue no. 1 povidone k30 water xylitol sorbitol magnesium stearate peppermint silicon dioxide

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2020-06-22

Purpose

Antacid

Description

Calcium carbonate 750 mg


Medication Information

Warnings



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

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

When using this product.

● Do not take more than 5 chewable tablets 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

● Constipation may occur

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Antacid

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.

● children under 12 years: consult a doctor.

● do not take more than 5 chewable tablets in a 24-hour period.

Other Information

● each chewable tablet contains: calcium 300 mg.

● contains FD&C Blue No. 1 as a color additive.

● store at room temperature. Avoid humidity.

Inactive Ingredients

Dextrose monohydrate, Saccharin sodium, Sucrose, Dokudami extract, FD&C Blue No. 1, Povidone K30, Water, Xylitol, Sorbitol, Magnesium Stearate, Peppermint, Silicon Dioxide

Description

Calcium carbonate 750 mg

Section 51945-4

Active Ingredient

Calcium carbonate 750 mg

Uses for the Relief Of



● acid indigestion.

● heartburn.

● sour stomach.

● upset stomach associated with these symptoms.


Structured Label Content

Warnings



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

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

When using this product.

● Do not take more than 5 chewable tablets 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

● Constipation may occur

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Antacid

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.

● children under 12 years: consult a doctor.

● do not take more than 5 chewable tablets in a 24-hour period.

Other Information (Other information)

● each chewable tablet contains: calcium 300 mg.

● contains FD&C Blue No. 1 as a color additive.

● store at room temperature. Avoid humidity.

Inactive Ingredients

Dextrose monohydrate, Saccharin sodium, Sucrose, Dokudami extract, FD&C Blue No. 1, Povidone K30, Water, Xylitol, Sorbitol, Magnesium Stearate, Peppermint, Silicon Dioxide

Section 51945-4 (51945-4)

Active Ingredient

Calcium carbonate 750 mg

Uses for the Relief Of (Uses for the relief of)



● acid indigestion.

● heartburn.

● sour stomach.

● upset stomach associated with these symptoms.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)