Sodium Bicarbonate
FDA Label NDC 50090-3021

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by A-s Medication Solutions for the product Sodium Bicarbonate (NDC 50090-3021). 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 - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, storage and handling, inactive ingredient, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Purpose

Purpose
Antacid

Indications & Usage

Uses: relieves • acid indigestion • heartburn • sour stomach • upset stomach associated with these symptoms

Warnings

Warnings
Do not take more 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 the maximum dosage for more than 2 weeks, except under the advice and supervision of a physician.
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.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.
In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

Dosage & Administration

Directions

  • do not use the maximum dosage for more than 2 weeks
  • tablets may be swallowed whole or dissolved in water prior to use
  • adults 60 years of age and over: 1-2 tablets every 4 hours, not more than 12 tablets in 24 hours
  • adults under 60 years of age: 1-4 tablets every 4 hours, not more than 24 tablets in 24 hours

Storage And Handling

Other Information:  Each tablet contains: sodium 178 mg (7.74 mEq) • store at room temperature 15°-30°C (59°-86°F) in a well closed container as defined in the USP.

Inactive Ingredient

Inactive Ingredients:  Croscarmellose sodium NF, microcrystalline cellulose NF, silica NF, stearic acid NF and talc USP.

Otc - Questions

Questions? 1-866-562-4597

Other

11790-11-16             REV 11/16

Manufactured for:                                 Manufactured by:
Rising Pharmaceuticals, Inc.                    Contract Pharmacal Corp.
Allendale, NJ 07401                                 Hauppauge, NY 11788

Lot No.:

Exp. Date:

How Supplied

Product: 50090-3021

NDC: 50090-3021-0 90 TABLET, ORALLY DISINTEGRATING in a BOTTLE

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