SODIUM BICARBONATE 10 GR- sodium bicarbonate tablet

Sodium Bicarbonate 10 gr by

Drug Labeling and Warnings

Sodium Bicarbonate 10 gr by is a Otc medication manufactured, distributed, or labeled by GRAXCELL PHARMACEUTICAL, LLC. 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 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 or 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

Drug Interaction Precaution

Stomach Warning

• TO AVOID SERIOUS INJURY, D0 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. Maxlmum 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.

D0 NOT EXCEED RECOMMENDED DOSE

Not recommended for children.

Other information

• each tablet contains : sodium 178 mg (7.74 meg)
• 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 mineral oil, USP

Questions or comments?

Call toll free 1-888-266-8818

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SODIUM BICARBONATE 10 GR 
sodium bicarbonate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70795-1190
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
STARCH, CORN (UNII: O8232NY3SJ)
MINERAL OIL (UNII: T5L8T28FGP)

Product Characteristics
Color	white	Score	2 pieces
Shape	ROUND	Size	11mm
Flavor		Imprint Code	G35
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70795-1190-0	1000 in 1 BOTTLE; Type 0: Not a Combination Product	10/02/2017
2	NDC: 70795-1190-5	500 in 1 BOTTLE; Type 0: Not a Combination Product	10/02/2017
3	NDC: 70795-1190-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	10/02/2017
4	NDC: 70795-1190-2	200 in 1 BOTTLE; Type 0: Not a Combination Product	10/02/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	10/02/2017

Labeler - GRAXCELL PHARMACEUTICAL, LLC (056556923)

Establishment
Name	Address	ID/FEI	Business Operations
GRAXCELL PHARMACEUTICAL, LLC		056556923	manufacture(70795-1190)