Sodium Bicarbonate Antacid Powder
FDA Label NDC 53145-390

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Menper Distributors Inc. for the product Sodium Bicarbonate Antacid (NDC 53145-390). 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, otc - purpose, indications & usage, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredient (in each dose=1/2 teaspoon)        Purpose

Sodium bicarbonate USP 2,616 mg ............................ Antacid

Otc - Purpose

Purpose

Antacid

Indications & Usage

Uses

Relieves: 

  • heartburn
  • sour stomach
  • acid indigestion
  • upset stomach associated with these syptoms

Warnings

Warnings

FOR ORAL USE ONLY

STOMACH WARNING: TO AVOID SERIOUS INJURY, DO NOT TAKE UNTIL POWDER IS COMPLETELY DISSOLVED. IT IS VERY IMPORTANT NOT TO TAKE THIS PRODUCT WHEN OVERLY FILL FROM FOOD OR DRINK.

Do not use in children under 12 years of age.

Ask a doctor or pharmacist before use if you have a sodium-restricted diet.

Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.

Stop use and ask a doctor if

  • you have used the maximum dosage for 2 wekks
  • sever stomach pain occurs after using this product

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. In case of overdose, get medical help or contact a Poison Control Center immediately.

Dosage & Administration

Directions

  • Take 1/2 teaspoon in 1/2 glass (4 fl. oz.) of water every 2 hours up to a maximum dosage or as directed by a doctor. Dissolve completely in water before drinking.
    •  Age Maximum Dosage
     Adults 60 years and overDo not exceed three doses of 1/2 teaspoon in a 24 hour period 
     Adults and children 12 years of age and overDo not exceed six doses of 1/2 teaspoon in a 24 hour period 
    Children under 12 years Do not use 

Inactive Ingredient

Inactive Ingredients:

Otc - Questions

Questions:

1-800-560-5223 M-F 9AM to 4PM Eastern

Menper Distributors Inc.

www.menperdistributors.com

Package Label.Principal Display Panel

Sodiumbic (Sodiumbicarbonate)

Sodiumbic (Sodiumbicarbonate)

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