SODIUM BICARBONATE 10 GR (650 MG)- sodium bicarbonate tablet

Sodium Bicarbonate by

Drug Labeling and Warnings

Sodium Bicarbonate by is a Otc medication manufactured, distributed, or labeled by Advanced Rx LLC, Ocean Healthcare Pvt Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 takemore 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.

Ask a doctor before use if you have

a sodium restricted diet.

Ask a doctor or pharmacist before use if you are

taking a presciption drug. Antacids may intract 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.

In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately (1-800-222-1222).

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

Other information

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

Inactive ingredients

Microcrystalline cellulose, stearic acid.

SPL UNCLASSIFIED SECTION

TEMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING.

Distributed by:

ADVANCED RX LLC

1942 NE 163rd St North Miami Beach,

FL33162 U.S.A

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SODIUM BICARBONATE   10 GR (650 MG)
sodium bicarbonate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80513-611
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)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	SB6
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80513-611-02	200 in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M001	09/01/2025

Labeler - Advanced Rx LLC (042795108)

Registrant - Advanced Rx LLC (042795108)

Establishment
Name	Address	ID/FEI	Business Operations
Ocean Healthcare Pvt Ltd		873673519	manufacture(80513-611)