SOUND HEALTH HEARTBURN AND GAS CHEWS- calcium carbonate tablet, chewable

Sound Health Heartburn and Gas Chews by

Drug Labeling and Warnings

Sound Health Heartburn and Gas Chews by is a Otc medication manufactured, distributed, or labeled by BestCo Inc., Bestco Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient (in each chewable tablet)

Calcium carbonate 750 mg

Simethicone 80 mg

PURPOSE

Purposes

Antacid

Anti-gas

INDICATIONS & USAGE

Uses: Relieves

Heartburn

Sour stomach

Acid indigestion

Upset stomach associated to these symptoms

Bloating, pressure or stuffed feeling commonly referred to as gas

WARNINGS

Warnings

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

ASK DOCTOR

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

Do not take more than 5 chewable tablets in a 24-hour period, or use the maxium dosage for more than 2 weeks, except under the advice and supervision of a physician.

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

DOSAGE & ADMINISTRATION

Directions Adults and children 12 years and older chew and swallow 1 to 2 chews every 2 - 4 housrs as needed. Do not exceed 5 chews in 24-ours. Children udner 12 years consult a doctor.

OTHER SAFETY INFORMATION

Other information

• Each chewable tablet contains: calcium 300mg
• Store between 20º to 25ºC (68º tp 77ºF) in a dry place
• Close cap tightly after use.

INACTIVE INGREDIENT

Inactive ingredients: Acacia gum, beeswax, carmine, carnauba wax, citric acid, corn starch, corn syrup, FD&C blue no. 1 aluminum lake, FD&C Blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, hydrogenated coconut oil, modified corn starch, natural and artificial flavors, phosphoric acid, pregelatinized corn starch, propylene glycol, purified water, shellac, sodium benzoate, sorbic acid, sorbitol, soy lecithin, sucrose and titanium dioxide.

QUESTIONS

Questions? Call 1-800-245-2898 Monday - Friday, 9am - 4pm EST

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SOUND HEALTH HEARTBURN AND GAS CHEWS 
calcium carbonate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52642-035
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CARBONATE	750 mg
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	80 mg

Inactive Ingredients
Ingredient Name	Strength
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	pink	Score	score with uneven pieces
Shape	ROUND	Size	14mm
Flavor	BERRY	Imprint Code	DR
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52642-035-82	82 in 1 BOTTLE; Type 0: Not a Combination Product	12/27/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	12/27/2019

Labeler - BestCo Inc. (002149136)

Registrant - BestCo Inc. (002149136)

Establishment
Name	Address	ID/FEI	Business Operations
Bestco Inc.		002149136	manufacture(52642-035)