Otc - Active Ingredient
Active Ingredients:
Sodium Bicarbonate USP 100% — Purpose: Antacid
Sodium Bicarbonate Powder
FDA Label NDC 69469-100
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Vitamex Usa, Corp for the product Sodium Bicarbonate (NDC 69469-100). 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, purpose, indications, warnings, do not use, doseage, other information, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Active Ingredients:
Sodium Bicarbonate USP 100% — Purpose: Antacid
Indications
Indications:
For the temporary relief of heartburn, sour stomach, acid indigestion, upset stomach associated with these symptoms.
Warnings
Warnings:
• For Oral use Only.
• To avoid serious injuries.
• Do not take until powder is completely dissolved.
• It is very important not to take this product when overly full from food or drink.
• Ask a doctor before use if:
- You have a sodium restricted diet.
- If you are presently taking a prescription.
Do Not Use
Do not use:
• In children under 12 years of age.
• If pregnant or breastfeeding.
Doseage
Directions:
• Take 1/2 level teaspoon in 1/2 glass (4 fl. oz.) of water every 2 hours up to maximum dosage or as directed by a doctor.
• Dissolve completely in water before drinking.
Other Information
Other Information:
• Store at 59° to 86°F.
• Do not use if foil seal is missing or broken.
• If serious symptoms occur get medical help or contact a Poison Control Center right away.
Other Safety Information
Maximum Dosage:
Adults and children 12 years and over:
• Do not exceed three doses of 1/2 teaspoon in a 24 hour period.
Children under 12 years:
• Do not use.
Inactice Ingredient
none
Keep Out Of Reach Of Children
Keep out of reach of children.
Do not use:
• In children under 12 years of age.
• If pregnant or breastfeeding.
Package Label.Principal Display Panel
Sodium Bicarbonate Label (Vitamexsb)
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