Sodium Bicarbonate 10 gr Tablets, USP Antacid

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC
Effective date
2020-07-06
Label type
Human OTC Drug Label
Version
1
Source
full-release
Hydrated at
2026-05-31 23:20:44

Label at a glance#

ProductSodium Bicarbonate
Active ingredientSODIUM BICARBONATE
Label structure13 sections

Boxed warning

                                                                       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#

BOXED WARNING SECTION

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

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:

Repackaging Information

SPL UNCLASSIFIED SECTION

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:

Count10 gr
6071610-438-53
9071610-438-60
12071610-438-70
18071610-438-80
36071610-438-94

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:
Aphena Pharma Solutions - TNAphena Pharma Solutions - TN
Cookeville, TN 38506

20200706JH

PRINCIPAL DISPLAY PANEL - 10 gr

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 71610-438 - Sodium Bicarbonate 10 gr Tablets
Bottle Label 10 grBottle Label 10 gr

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198861sodium bicarbonate 650 MG Oral TabletPSN1
198861sodium bicarbonate 650 MG Oral TabletSCD1
198861NaHCO3 650 MG Oral TabletSY1
198861sodium bicarbonate 10 Grains Oral TabletSY1
198861sodium bicarbonate 648 MG Oral TabletSY1

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
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-438-53Sodium Bicarbonate60 in 1 BOTTLETABLET601
71610-438-60Sodium Bicarbonate90 in 1 BOTTLETABLET901
71610-438-80Sodium Bicarbonate180 in 1 BOTTLETABLET1801
71610-438-94Sodium Bicarbonate360 in 1 BOTTLETABLET3601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-438SODIUM BICARBONATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 4 package rows20200709_f7ebb41a-d483-442a-95a0-47706cf3ee9a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-438-53EA - Each71610-4388efe719b-7b96-420f-85ef-b082d4a715ea12020-08-06
71610-438-60EA - Each71610-43899a9a712-4830-43a2-81c0-1de3b46d277212020-08-06
71610-438-80EA - Each71610-4387fe21e47-d911-4b48-833c-75e4f30a7beb12020-08-06
71610-438-94EA - Each71610-43821a47732-b56f-4fb9-9c74-7a5fcb078be512020-08-06
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
71610-43871610-438-53, 71610-438-60, 71610-438-80, 71610-438-94
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
8c2fd216-d341-4bfb-a25b-6e04602d34bbf7ebb41a-d483-442a-95a0-47706cf3ee9a2020-07-06Boxed warning, WarningsExact identifier
spl id: 8c2fd216-d341-4bfb-a25b-6e04602d34bb
spl set id: f7ebb41a-d483-442a-95a0-47706cf3ee9a

Reported adverse events (FAERS/openFDA)#

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