SODIUM BICARBONATE tablet

SODIUM BICARBONATE by

Drug Labeling and Warnings

SODIUM BICARBONATE by is a Otc medication manufactured, distributed, or labeled by Ingenus Pharmaceuticals NJ, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient (in each tablet)

Sodium bicarbonate 10 gr (650 mg)

PURPOSE

Antacid

Indications:

Relieves:

• acid indigestion
• heartburn
• sour stomach
• upset stomach

associated with these symptoms

Warnings

Do not use this 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 the 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 advise 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:

Antacids may interact with certain prescription drugs. If you are presently taking a prescription drug, do not take this product without checking with your physician or other health professional.

Directions:

• Adults - Take 1 tablet, dissolved in a glass of water, as needed.
• Maximum daily dose for adults upto 60 years of age is 24 tablets.
• Maximum daily dose for adults 60 years of age and 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 15°- 30°C (59°- 86°F) in well-closed containers as defined in the USP.

Inactive Ingredients:

Pregelatinized starch, NF and mieral oil, USP.

KEEP OUT OF REACH OF CHILDREN

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

OVERDOSAGE

In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

PRINCIPAL DISPLAY PANEL

ingenus

NDC: 52682-206-04

SODIUM BICARBONATE

10 gr (650 mg)

Antacid

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN.

1000 Tablets

Mfd. by Ingenus Pharmaceuticals NJ, LLC

Fairfield, NJ 07004

INGREDIENTS AND APPEARANCE

SODIUM BICARBONATE 
sodium bicarbonate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52682-206
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
MINERAL OIL (UNII: T5L8T28FGP)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	WHITE (White)	Score	2 pieces
Shape	ROUND (round)	Size	11mm
Flavor		Imprint Code	CL;206
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52682-206-04	1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/24/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	01/24/2011

Labeler - Ingenus Pharmaceuticals NJ, LLC (964680206)

Registrant - Ingenus Pharmaceuticals NJ, LLC (964680206)

Establishment
Name	Address	ID/FEI	Business Operations
Ingenus Pharmaceuticals NJ, LLC		964680206	manufacture(52682-206) , analysis(52682-206) , label(52682-206) , pack(52682-206)