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NDC 43353-0041-85 Sodium Bicarbonate 650 mg/1 Details

Sodium Bicarbonate 650 mg/1

Sodium Bicarbonate is a ORAL TABLET, ORALLY DISINTEGRATING in the HUMAN OTC DRUG category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, LLC. 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: 43353-0041-85
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Sodium Bicarbonate

Product Information

NDC	43353-0041
Product ID	43353-041_a33fd71a-4174-4989-82f2-6c8c39e187b3
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, ORALLY DISINTEGRATING
Route	ORAL
Active Ingredient Strength	650
Active Ingredient Units	mg/1
Substance Name	SODIUM BICARBONATE
Labeler Name	Aphena Pharma Solutions - Tennessee, LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part331
Listing Certified Through	2024-12-31

Package

Package Images

NDC 43353-0041-85 (43353004185)

Pricing Information	N/A
NDC Package Code	43353-041-85
Billing NDC	43353004185
Package	200 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (43353-041-85)
Marketing Start Date	2015-06-06
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 7ac1638a-1b1f-4407-a8f4-190de4d58736 Details

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.

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

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

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

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

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

Revised: 8/2017

Document Id: a33fd71a-4174-4989-82f2-6c8c39e187b3

Set id: 7ac1638a-1b1f-4407-a8f4-190de4d58736

Version: 2

Effective Time: 20170818

Search by Drug Name or NDC

NDC 43353-0041-85 Sodium Bicarbonate 650 mg/1 Details

Sodium Bicarbonate 650 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 43353-0041-85 (43353004185)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 7ac1638a-1b1f-4407-a8f4-190de4d58736 Details

Drug Facts

Indications:

Warnings

Stomach Warning:

SPL UNCLASSIFIED SECTION

Drug Interaction Precaution:

Directions:

Other Information:

Inactive Ingredients:

SPL UNCLASSIFIED SECTION

Repackaging Information

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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