SODIUM BICARBONATE- sodium bicarbonate tablet, orally disintegrating

Sodium Bicarbonate by

Drug Labeling and Warnings

Sodium Bicarbonate by is a Otc medication manufactured, distributed, or labeled by Aphena Pharma Solutions - Tennessee, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

• Active ingredients (in each tablet) Sodium Bicarbonate 10 gr (650mg): 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 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.

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.

INDICATIONS & USAGE

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.

Directions:

Adults -Take 1 tablet, dissolved in a glass of water, as needed. Maximum 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. 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 mineral oil, USP.

KEEP OUT OF REACH OF CHILDREN

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.

Repackaging Information

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

• Count: 650mg
• 60: 43353-041-53
• 90: 43353-041-60
• 120: 43353-041-70
• 180: 43353-041-80
• 200: 43353-041-85
• 360: 43353-041-94

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:

Cookeville, TN 38506

20160628DH

PRINCIPAL DISPLAY PANEL

      NDC: 43353-041-53

Sodium
Bicarbonate
Antacid

60 Tablets

INGREDIENTS AND APPEARANCE

SODIUM BICARBONATE  
sodium bicarbonate tablet, orally disintegrating

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43353-041(NDC: 64980-182)
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
STARCH, CORN (UNII: O8232NY3SJ)
MINERAL OIL (UNII: T5L8T28FGP)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	CL;206
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43353-041-53	60 in 1 BOTTLE; Type 0: Not a Combination Product	07/14/2015
2	NDC: 43353-041-60	90 in 1 BOTTLE; Type 0: Not a Combination Product	05/17/2015
3	NDC: 43353-041-70	120 in 1 BOTTLE; Type 0: Not a Combination Product	06/16/2015
4	NDC: 43353-041-80	180 in 1 BOTTLE; Type 0: Not a Combination Product	06/05/2015
5	NDC: 43353-041-85	200 in 1 BOTTLE; Type 0: Not a Combination Product	06/06/2015
6	NDC: 43353-041-94	360 in 1 BOTTLE; Type 0: Not a Combination Product	07/30/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	06/26/2012

Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585)

Establishment
Name	Address	ID/FEI	Business Operations
Aphena Pharma Solutions - Tennessee, LLC		128385585	REPACK(43353-041)