SODIUM BICARBONATE 5 GR (325 MG)- sodium bicarbonate tablet

Sodium Bicarbonate by

Drug Labeling and Warnings

Sodium Bicarbonate by is a Otc medication manufactured, distributed, or labeled by CitraGen Pharmaceuticals Inc., CitraGen Pharmaceuticals Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each tablet)

Sodium Bicarbonate 5 gr (325 mg)

Purpose

Antacid

Uses

relieves:

acid indigestion
heartburn
sour stomach
upset stomach associated with these symptoms

Warnings

Do not take more than 48 tablets for adults up to 60 years of age (or 24 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 before use 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.

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

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: 2-4 tablets every 4 hours, not more than 24 tablets in 24 hours
• adults under 60 years of age: 2-8 tablets every 4 hours, not more than 48 tablets in 24 hours

Other information

each tablet contains: sodium 89 mg

store at room temperature 15° - 30°C (59° - 86°F)

Inactive ingredients

Hydrogenated Vegetable Oil, NF and Microcrystalline Cellulose, NF

Questions or comments?

Phone: +1-510-249-9066 (9AM-5PM PST, Mon-Fri); e-mail: info@citragenpharma.com

SPL UNCLASSIFIED SECTION

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

Manufactured by:
CitraGen Pharmaceuticals, Inc.,
Fremont, CA 94538.

www.citragenpharma.com

Rev. 03/18 R-00

PRINCIPAL DISPLAY PANEL

CitraGen Pharmaceuticals, Inc.

NDC: 70369-002-01

Sodium Bicarbonate Tablets, USP 5 gr (325 mg)

ANTACID

1000 Tablets

THIS PACKAGE IS FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

INGREDIENTS AND APPEARANCE

SODIUM BICARBONATE  5 GR (325 MG)
sodium bicarbonate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70369-002
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM BICARBONATE	325 mg

Inactive Ingredients
Ingredient Name	Strength
HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

Product Characteristics
Color	white	Score	2 pieces
Shape	ROUND	Size	9mm
Flavor		Imprint Code	CG002
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70369-002-01	1000 in 1 BOTTLE; Type 0: Not a Combination Product	04/20/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	04/20/2018

Labeler - CitraGen Pharmaceuticals Inc. (024949457)

Registrant - CitraGen Pharmaceuticals Inc. (024949457)

Establishment
Name	Address	ID/FEI	Business Operations
CitraGen Pharmaceuticals Inc		024949457	manufacture(70369-002)