Active Ingredient (In Each Tablet)
Sodium Bicarbonate 5 gr (325 mg)
Sodium Bicarbonate 5 Gr Tablet
FDA Label NDC 55681-072
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Twin Med Llc for the product Sodium Bicarbonate 5 Gr (NDC 55681-072). 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 active ingredient (in each tablet), purpose, uses, warnings, otc - do not use, otc - stop use, other, 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
Otc - Do Not Use
Do not use this product if you are on a sodium-restricted diet unless directed by a doctor.
Do not takemore 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 maximum dosage for more than 2 weeks, except under the advice and supervision of a doctor.
Otc - Stop Use
Stop use and ask a doctor ifsymptoms last more than 2 weeks.
Other
Stomach Warning: TO AVOID SERIOUS INJURY, D0 NOT TAKE UNTIL TABLET IS COMPLETELY DISSOLVED. IT IS VERY IMPORTANT NOT TO TAKE THIS PRODUCT WHEN OVERLY FULL FROM FOOD OR DRINK. Consult a doctor if severe stomach pain occurs after taking this product.
Drug Interaction Precaution: Ask a physician or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.
Manufactured for:
TwinMed LLC.
11333 Greenstone Ave
Santa Fe Springs, CA 90670
ProCureProducts.com
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.
Directions
Adults: Take 1 tablet, dissolved in a glass of water, as needed.
Maximum daily dose for adults up to 60 years of age is 24 tablets.
Maximum daily dose for adults 60 years of age or older is 12 tablets.
Dissolve completely in water before drinking.
DO NOT EXCEED RECOMMENDED DOSE.
Not recommended for children.
Other Information
- each tablet contains:sodium 89 mg
- store at room temperature 15°-30°C (59°-86°F) in well-closed containers as defined in the USP
- DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED
Inactive Ingredients
Pregelatinized Starch and Mineral Oil
Questions?
call toll-free 1-844-912-4012
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