Sodium Bicarbonate Antacid
FDA Label NDC 70242-131

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dannso Corp./d.b.a. Essential Products for the product Sodium Bicarbonate Antacid (NDC 70242-131). 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 dose = 1/2 teaspoon), purpose, uses, warnings, stomach warning, otc - do not use, ask a doctor before use if you have, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient (In Each Dose = 1/2 Teaspoon)

Sodium bicarbonate USP 2,616 mg

Purpose

Antacid

Uses

Relieves:

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

Warnings

FOR ORAL USE ONLY

Do not use if Tamper Evident Seal is missing or broken.

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 FULL FROM FOOD OR DRINK.

Otc - Do Not Use

Do not use in children under 12 years of age.

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 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 weeks
  • severe stomach pain occurs after using this product

Otc - Pregnancy Or Breast Feeding

If pregnant or breastfeeding, 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.

Directions

  • take ½ level teaspoon in ½ 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.
    • AgeMaximum Dosage
    Adults 60 years and overDo not exceed three doses of 1/2 teaspoon in a 24 hour period.
    Adults and children 12 years and overDo not exceed six doses of 1/2 teaspoon in a 24 hour period.
    Children under 12 yearsDo not use.

    Do not exceed recommended dosage. See warnings.

Other Information

  • each 1/2 teaspoon dose contains: sodium 716 mg

Questions

1-800-858-3889

Principal Display Panel - 113 G Bottle Label

De La Cruz®

Sodium
Bicarbonate
USP
- Oral Powder -

Antacid

NET WT 4 OZ (113 g)

Principal Display Panel (113 g Bottle Label)

Principal Display Panel (113 g Bottle Label)

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