Drug Facts
Active ingredient (in each tablet)
Sodium bicarbonate 10 gr (650 mg)
Sodium Bicarbonate Tablet
FDA Label NDC 0904-7261
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Major Pharmaceuticals for the product Sodium Bicarbonate (NDC 0904-7261). 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, otc - purpose, uses, otc - do not use, 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
Otc - Purpose
Purpose
Antacid
Uses
relieves:
acid indigestion
heartburn
sour stomach
upset stomach associated with these symptoms
Otc - Do Not Use
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.
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, get medical help or contact a Poison Control Center right away (1-800-222-1222).
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
Other Information
each tablet contains: sodium 178 mg
store in a dry place at 15° – 30°C (59° – 86°F) Retain this carton for
important information.
Inactive Ingredient
croscarmellose sodium, microcrystalline cellulose, silica, stearic acid and talc
Questions Or Comments?
(800) 616-2471
Other
Unit Dose
Sodium Bicarbonate
DO NOT USE IF CARTON IS OPENED OR IF A BLISTER UNIT IS TORN, BROKEN, OR SHOWS ANY SIGNS OF TAMPERING.
Distributed by:
MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268
www.majorpharmaceuticals.com
WARNING: This product can expose you to chemicals including
lead, which is known to the State of California to cause cancer
and birth defects or other reproductive harm. For more information
go to www.P65Warnings.ca.gov.
Package Label.Principal Display Panel
NDC 0904-7261-61
MAJOR®
Unit Dose
Sodium Bicarbonate
Antacid
10 gr (650 mg)
100 Tablets
* Please review the disclaimer below.
