SODIUM BICARBONATE tablet

Sodium Bicarbonate by

Drug Labeling and Warnings

Sodium Bicarbonate by is a Otc medication manufactured, distributed, or labeled by TWIN MED LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

Sodium Bicarbonate 10 gr (650 mg)

Purpose

Antacid

Uses

relieves

• acid indigestion
• heartburn
• sour stomach
• upset stomach associated with these symptoms

Warnings

Do not usethis product if you are on a sodium-restricted diet unless directed by a doctor. Do not take more than 24 tablets for adults up to 60 years of age (or 12 tablets for adults 60 years of age and older) in a 24 hour period nor use maximum dosage for more than 2 weeks, except under the advice and supervision of a physician. As with any drug, if you are pregnant or nursing a baby, seek advice of a health professional before using this product.

Stomach Warning

TO AVOID SERIOUS INJURY, DO NOT TAKE UNTIL TABLET IS COMPLETELY DISSOLVED IT IS VERY IMPORTANT NOT TO TAKE THIS PRODUCT WHEN OVERLY FULL FROM FOOD OR DRINK.

Consult a doctor if severe stomach pain occurs after taking this product.

Drug Interaction Precaution

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

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

Directions

Adults

Take 1 tablet, dissolved in a glass of water, as needed. Maximum daily dose for adults up to 60 years of age is 24 tablets. Maximum daily dose for adults 60 years of age or older is 12 tablets. Dissolve completely in water before drinking.

DO NOT EXCEED RECOMMENDED DOSE.Not recommended for children.

Other information

• each tablet contains: sodium 178 mg (7.74 mEq)
• store at room temperature 15º-30ºC (59º-86°F) in a well-closed container as defined in the USP

Inactive ingredients

Microcrystalline cellulose and stearic acid, magnesium stearate

Questions or comments?

Questions ? call toll-free 1-844-912-4012

PRINCIPAL DISPLAY PANEL - 1000 Tablet Bottle Label

NDC: 55681-331-10

Sodium Bicarbonate

Tablets, USP

10 gr (650 mg)

ANTACID

INGREDIENTS AND APPEARANCE

SODIUM BICARBONATE 
sodium bicarbonate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55681-331
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20)	SODIUM BICARBONATE	650 mg

Inactive Ingredients
Ingredient Name	Strength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
STEARIC ACID (UNII: 4ELV7Z65AP)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	S65
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55681-331-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	10/10/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M001	10/10/2022

Labeler - TWIN MED LLC (009579330)

Establishment
Name	Address	ID/FEI	Business Operations
Neeyaan, LLC		118819217	manufacture(55681-331)