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NDC 54738-0020-03 SODIUM BICARBONATE 650 mg/1 Details

SODIUM BICARBONATE 650 mg/1

SODIUM BICARBONATE is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Richmond Pharmaceuticals, Inc.. The primary component is SODIUM BICARBONATE.

MedlinePlus Drug Summary

Sodium bicarbonate is an antacid used to relieve heartburn and acid indigestion. Your doctor also may prescribe sodium bicarbonate to make your blood or urine less acidic in certain conditions. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Related Packages: 54738-0020-03
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Sodium Bicarbonate

Product Information

NDC	54738-0020
Product ID	54738-020_5cc6cec2-9f03-6cf9-e053-2991aa0ada77
Associated GPIs	48200010000325
GCN Sequence Number	002661
GCN Sequence Number Description	sodium bicarbonate TABLET 650 MG ORAL
HIC3	D4B
HIC3 Description	ANTACIDS
GCN	07855
HICL Sequence Number	000523
HICL Sequence Number Description	SODIUM BICARBONATE
Brand/Generic	Generic
Proprietary Name	SODIUM BICARBONATE
Proprietary Name Suffix	n/a
Non-Proprietary Name	SODIUM BICARBONATE
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	650
Active Ingredient Units	mg/1
Substance Name	SODIUM BICARBONATE
Labeler Name	Richmond Pharmaceuticals, Inc.
Pharmaceutical Class	Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part331
Listing Certified Through	2024-12-31

Package

Package Images

NDC 54738-0020-03 (54738002003)

Pricing Information	N/A
NDC Package Code	54738-020-03
Billing NDC	54738002003
Package	1000 TABLET in 1 BOTTLE, PLASTIC (54738-020-03)
Marketing Start Date	2015-05-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL fa10d93d-b3ed-4675-a117-f573d9e72bca Details

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

Ask a doctor or pharmacist

if you are on a sodium-restricted diet.
if you are taking a prescription drug. Antacids may interact with certain prescription drugs.
if symptons last more than 2 weeks

As with any drug, if you are pregnant or nursing a baby, seek advise of a health professional before using this product.

Directions:

Adults 60years of age and over - 1-2 tablets every 4 hours. Not more than 12 tablets in 24 hours
Adults under 60 years- 1-4 tablets every4 hours. Not more than 24 tablets in 24 hours
Dissolve tabelt completely in water before drinking.
DO NOT EXCEED RECOMMENDED DOSE. Not recommended for children.

Other Information:

each tablet contains: sodium 178 mg
store at room temperature 15 °- 30 °C (59 °- 86 °F).

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

INACTIVE INGREDIENT

croscarmellose sodium, microcrystalline cellulose, stearic acid

Questions or Comments

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

call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday

Principal display panel

INGREDIENTS AND APPEARANCE

SODIUM BICARBONATE

sodium bicarbonate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54738-020
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM BICARBONATE	650 mg

Ingredient Name	Strength
Inactive Ingredients
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white (White)	Score	no score
Shape	ROUND (round)	Size	11mm
Flavor		Imprint Code	AP;119
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54738-020-03	1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/01/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part331	05/01/2015

Labeler - Richmond Pharmaceuticals, Inc. (043569607)

Registrant - Advance Pharmaceutical Inc. (078301063)

Name	Address	ID/FEI	Business Operations
Establishment
Advance Pharmaceutical Inc.		078301063	manufacture(54738-020)

Revised: 10/2017

Document Id: 5cc6cec2-9f03-6cf9-e053-2991aa0ada77

Set id: fa10d93d-b3ed-4675-a117-f573d9e72bca

Version: 3

Effective Time: 20171030

Search by Drug Name or NDC

NDC 54738-0020-03 SODIUM BICARBONATE 650 mg/1 Details

SODIUM BICARBONATE 650 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 54738-0020-03 (54738002003)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL fa10d93d-b3ed-4675-a117-f573d9e72bca Details

Drug Facts

PURPOSE

Indications:

Warnings

Ask a doctor or pharmacist

Directions:

Other Information:

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

INACTIVE INGREDIENT

Questions or Comments

Principal display panel

INGREDIENTS AND APPEARANCE

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