Sodium Bicarbonate 10 gr Tablets, USP Antacid

Manufacturer
A-S Medication Solutions
Effective date
2018-07-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:56:34

Label at a glance#

ProductSodium Bicarbonate
Active ingredientSODIUM BICARBONATE
Label structure12 sections

Storage and handling

Other Information:  Each tablet contains: sodium 178 mg (7.74 mEq) • store at room temperature 15°-30°C (59°-86°F) in a well closed container as defined in the USP.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts
Active ingredients (in each tablet)

Sodium Bicarbonate 10 gr (650mg)

OTC - PURPOSE SECTION

Purpose
Antacid

INDICATIONS & USAGE SECTION

Uses: relieves • acid indigestion • heartburn • sour stomach • upset stomach associated with these symptoms

WARNINGS SECTION

Warnings
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 the maximum dosage for more than 2 weeks, except under the advice and supervision of a physician.
Ask a doctor before use if you have a sodium restricted diet.
Ask a doctor or pharmacist before use if you are taking a prescription drug.
Antacids may interact with certain prescription drugs.
Stop use and ask a doctor if symptoms last more than 2 weeks
If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.
In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION SECTION

Directions

  • do not use the maximum dosage for more than 2 weeks
  • tablets may be swallowed whole or dissolved in water prior to use
  • adults 60 years of age and over: 1-2 tablets every 4 hours, not more than 12 tablets in 24 hours
  • adults under 60 years of age: 1-4 tablets every 4 hours, not more than 24 tablets in 24 hours

STORAGE AND HANDLING SECTION

Other Information:  Each tablet contains: sodium 178 mg (7.74 mEq) • store at room temperature 15°-30°C (59°-86°F) in a well closed container as defined in the USP.

INACTIVE INGREDIENT SECTION

Inactive Ingredients:  Croscarmellose sodium NF, microcrystalline cellulose NF, silica NF, stearic acid NF and talc USP.

OTC - QUESTIONS SECTION

Questions? 1-866-562-4597

SPL UNCLASSIFIED SECTION

11790-11-16             REV 11/16

Manufactured for:                                 Manufactured by:
Rising Pharmaceuticals, Inc.                    Contract Pharmacal Corp.
Allendale, NJ 07401                                 Hauppauge, NY 11788

Lot No.:

Exp. Date:

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-3021

NDC: 50090-3021-0 90 TABLET, ORALLY DISINTEGRATING in a BOTTLE

sodium bicarbonate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BICARBONATE ION Pharmacologic Class Indexing1Indexing - Pharmacologic Class20220121

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3021-02020-01-31C16284748780-19d75b9d0-e6da-f424-e053-dadaa90a57ceSodium Bicarbonate 10 gr Tablets, USP Antacid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3021-0Sodium Bicarbonate90 in 1 BOTTLETABLET, ORALLY DISINTEGRATING902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3021SODIUM BICARBONATE (SODIUM BICARBONATE) TABLET, ORALLY DISINTEGRATING [A-S MEDICATION SOLUTIONS]2Legacy NDC, 1 package rows20180809_79a20a28-10a0-4b4e-bb6c-d8a589fdd40b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3021-0EA - Each50090-3021e0055e3c-253a-4bc4-9191-a3f122069a9012019-05-02
64980-294-10EA - Each64980-29417cd9e04-2352-4d9c-9537-bcff09c8becd12017-08-11

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50090-302150090-3021-0
64980-294

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b54a42c2-3492-4db4-8fbd-cd401551f71579a20a28-10a0-4b4e-bb6c-d8a589fdd40b2018-07-26Boxed warning, WarningsExact identifier
spl id: b54a42c2-3492-4db4-8fbd-cd401551f715
spl set id: 79a20a28-10a0-4b4e-bb6c-d8a589fdd40b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.