Otc - Active Ingredient
Drug Facts
Active ingredients (in each tablet)
Sodium Bicarbonate 10 gr (650mg)
Sodium Bicarbonate Tablet
FDA Label NDC 24689-137
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Apnar Pharma Lp for the product Sodium Bicarbonate (NDC 24689-137). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, storage and handling, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Antacid
Indications & Usage
Uses: relieves • acid indigestion • heartburn • sour stomach • upset stomach associated with these symptoms
Warnings
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
Keep out of reach of children.
In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.
Dosage & Administration
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
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
Inactive Ingredients: Microcrystalline cellulose NF, Hydrogenated Vegetable oil NF
Otc - Questions
Questions or Comments?
Phone +1-855-642-2594
Other
Rev.: 04/2022
MADE IN USA
Manufactured by:
APNAR PHARMA LLP
East Windsor
NJ 08520
Boxed Warning
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Sodium Bicarbonate Tablets,Usp 10Gr (650Mg)-1000 Tablets
NDC : 24689-137-01
Sodium
Bicarbonate 10 gr TABLETS, USP
Antacid
THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN.
1000 Tablets
* Please review the disclaimer below.
