Sodium Bicarbonate 10 gr Tablets, USP Antacid

Drug Details [pdf]

SODIUM BICARBONATE - sodium bicarbonate tablet, orally disintegrating
Rising Pharmaceuticals, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Sodium Bicarbonate 10 gr Tablets, USP
Antacid

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 PRODUCTWHEN 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.

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 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.

PRINCIPAL DISPLAY PANEL-1000 tablets

Rising® NDC: 64980-182-10

Sodium
Bicarbonate
10 gr TABLETS, USP
Antacid

THIS PACKAGE FOR HOUSEHOLDS
WITHOUT YOUNG CHILDREN.

1000 Tablets

SODIUM BICARBONATE
sodium bicarbonate tablet, orally disintegrating

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64980-182
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20)	SODIUM BICARBONATE	650 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 64980-182-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	06/26/2012	04/18/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part331	06/26/2012	04/18/2019

Labeler - Rising Pharmaceuticals, Inc. (041241766)

Registrant - Ingenus Pharmaceuticals NJ, LLC (964680206)

Name	Address	ID/FEI	Business Operations
Establishment
Ingenus Pharmaceuticals NJ, LLC		964680206	ANALYSIS(64980-182) , LABEL(64980-182) , MANUFACTURE(64980-182) , PACK(64980-182)

Revised: 11/2019

Document Id: b393d910-e651-4c22-a97f-f7ff6408b53b

Set id: 0ed99c62-aec3-4f3f-acb3-bd43c9d7ed4d

Version: 2

Effective Time: 20191108

Rising Pharmaceuticals, Inc.