Sodium Bicarbonate Tablets, USP 10gr (650mg)

Manufacturer
APNAR PHARMA LP | INVAHEALTH INC | APNAR PHARMA LLP
Effective date
2023-10-21
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:57:09

Label at a glance#

ProductSodium Bicarbonate
Active ingredientSODIUM BICARBONATE
Label structure12 sections

Boxed warning

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

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

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 beforeuse 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: Microcrystalline cellulose NF, Hydrogenated Vegetable oil NF

OTC - QUESTIONS SECTION

Questions or Comments?

Phone +1-855-642-2594

SPL UNCLASSIFIED SECTION

Rev.: 04/2022

MADE IN USA

Manufactured by:

APNAR PHARMA LLP

East Windsor

NJ 08520

BOXED WARNING SECTION

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

Sodium Bicarbonate Tablets,USP 10gr (650mg)-1000 Tablets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC : 24689-137-01

Sodium
Bicarbonate 10 gr TABLETS, USP
Antacid

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN.

1000 Tablets

Label-Sodium Bicarbonate Tablets USP 650mg 1000s countLabel-Sodium Bicarbonate Tablets USP 650mg 1000s count

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198861sodium bicarbonate 650 MG Oral TabletPSN4
198861sodium bicarbonate 650 MG Oral TabletSCD4
198861NaHCO3 650 MG Oral TabletSY4
198861sodium bicarbonate 10 Grains Oral TabletSY4
198861sodium bicarbonate 648 MG Oral TabletSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
SODIUM CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
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6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
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6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24689-137-01Sodium Bicarbonate1000 in 1 BOTTLETABLET10004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24689-137SODIUM BICARBONATE TABLET [APNAR PHARMA LP]4Current NDC, Legacy NDC, 1 package rows20231021_e206c240-55c2-2d00-e053-2a95a90a1779.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24689-137-01EA - Each24689-1379e81dd61-0c63-481e-9ee7-f447b94f75f312022-08-04

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
24689-13724689-137-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 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
Sodium BicarbonateSODIUM BICARBONATEAPNAR PHARMA LPe206c240-55c2-2d00-e053-2a95a90a17792023-10-21Boxed warning, WarningsExact identifier
ndc (package): 24689-137-01
ndc (product): 24689-137
ndc11 (package): 24689013701
spl id: 08352100-b59d-c799-e063-6294a90a5e3b
spl set id: e206c240-55c2-2d00-e053-2a95a90a1779

Reported adverse events (FAERS/openFDA)#

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