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TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Distributed by: Reliable 1 Laboratories LLC
Valley Stream, NY 11580
Sodium Bicarbonate 5 Gr
FDA Label NDC 69618-035
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Reliable 1 Laboratories Llc for the product Sodium Bicarbonate 5 Gr (NDC 69618-035). 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 other, active ingredient (in each tablet), purpose, indications & usage, warnings, otc - ask doctor, otc - ask doctor/pharmacist, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Tablet)
Sodium bicarbonate 5 gr
Purpose
Antacid
Indications & Usage
Uses relieves
- acid indigestion
- heartburn
- sour stomach
- upset stomach associated with these symptoms
Warnings
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.
Keep out of reach of children.
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 - Keep Out Of Reach Of Children
Keep out of reach of children.
Directions
- do not use the maximum dosage for more than 2 weeks
- dissolve tablets completely in water prior to use
- adults 60 years of age and over: 2-8 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
croscarmellose sodium, microcrystalline cellulose, stearic acid
Questions Or Comments?
call 516-341-0666, 8:30 am-4:30 pm ET, Monday-Friday
Package Label.Principal Display Panel
NDC 69618-035-10
Sodium Bicarbonate 5 gr
ANTACID
1000 TABLETS
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