SODIUM BICARBONATE tablet

Sodium Bicarbonate by

Drug Labeling and Warnings

Sodium Bicarbonate by is a Otc medication manufactured, distributed, or labeled by APNAR PHARMA LP, APNAR PHARMA LLP, INVAHEALTH INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts
Active ingredients (in each tablet)

Sodium Bicarbonate 10 gr (650mg)

PURPOSE

Antacid

INDICATIONS & USAGE

Uses: relieves acid indigestion heartburn sour stomach upset stomach associated with these symptoms

WARNINGS

Warnings

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 the maximum dosage for more than 2 weeks, except under the advice and supervision of a physician.

Ask a doctor beforeuse if you have a sodium restricted diet.

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

Stop use and ask a doctor if symptoms last more than 2 weeks

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION

Directions

• do not use the maximum dosage for more than 2 weeks
• tablets may be swallowed whole or dissolved in water prior to use
• adults 60 years of age and over: 1-2 tablets every 4 hours, not more than 12 tablets in 24 hours
• adults under 60 years of age: 1-4 tablets every 4 hours, not more than 24 tablets in 24 hours

STORAGE AND HANDLING

Other Information:

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

INACTIVE INGREDIENT

Inactive Ingredients: Microcrystalline cellulose NF, Hydrogenated Vegetable oil NF

QUESTIONS

Questions or Comments?

Phone +1-855-642-2594

SPL UNCLASSIFIED SECTION

Rev.: 04/2022

MADE IN USA

Manufactured by:

APNAR PHARMA LLP

East Windsor

NJ 08520

BOXED WARNING

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TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Sodium Bicarbonate Tablets,USP 10gr (650mg)-1000 Tablets

NDC : 24689-137-01

Sodium
Bicarbonate 10 gr TABLETS, USP
Antacid

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN.

1000 Tablets

INGREDIENTS AND APPEARANCE

SODIUM BICARBONATE 
sodium bicarbonate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24689-137
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM BICARBONATE	650 mg

Inactive Ingredients
Ingredient Name	Strength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CORN OIL (UNII: 8470G57WFM)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	AS3
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24689-137-01	1000 in 1 BOTTLE; Type 0: Not a Combination Product	06/24/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M001	06/24/2022

Labeler - APNAR PHARMA LP (079568229)

Establishment
Name	Address	ID/FEI	Business Operations
INVAHEALTH INC		116840615	label(24689-137) , pack(24689-137)

Establishment
Name	Address	ID/FEI	Business Operations
APNAR PHARMA LLP		118530917	manufacture(24689-137) , analysis(24689-137) , pack(24689-137)