Drug Facts
Active ingredient (in each tablet)
Sodium Bicarbonate 5 gr (325 mg)
Sodium Bicarbonate Tablet
FDA Label NDC 70369-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Citragen Pharmaceuticals Inc. for the product Sodium Bicarbonate (NDC 70369-002). 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 drug facts, purpose, uses, warnings, otc - ask doctor, otc - ask doctor/pharmacist, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antacid
Uses
relieves:
acid indigestion
heartburn
sour stomach
upset stomach associated with these symptoms
Warnings
Do not take more than 48 tablets for adults up to 60 years of age (or 24 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.
Otc - Ask Doctor
Ask a doctor before use if you have a sodium restricted diet.
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking a prescription drug.
Antacids may interact with certain prescription drugs.
Otc - Stop Use
Stop use and ask a doctor if symptoms last more than 2 weeks.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdosage
In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.
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: 2-4 tablets every 4 hours, not more than 24 tablets in 24 hours
- adults under 60 years of age: 2-8 tablets every 4 hours, not more than 48 tablets in 24 hours
Other Information
each tablet contains: sodium 89 mg
store at room temperature 15° - 30°C (59° - 86°F)
Inactive Ingredients
Hydrogenated Vegetable Oil, NF and Microcrystalline Cellulose, NF
Questions Or Comments?
Phone: +1-510-249-9066 (9AM-5PM PST, Mon-Fri); e-mail: [email protected]
Other
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Manufactured by:
CitraGen Pharmaceuticals, Inc.,
Fremont, CA 94538.
Rev. 03/18 R-00
Package Label.Principal Display Panel
CitraGen Pharmaceuticals, Inc.
NDC: 70369-002-01
Sodium Bicarbonate Tablets, USP 5 gr (325 mg)
ANTACID
1000 Tablets
THIS PACKAGE IS FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN
Bottle Label (Bottle Label 70369 002 01)
* Please review the disclaimer below.
