Sodium Bicarbonate Tablet
FDA Label NDC 64980-528

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rising Pharma Holdings, Inc. for the product Sodium Bicarbonate (NDC 64980-528). 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 boxed warning, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Boxed Warning


DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Otc - Active Ingredient

Drug Facts
Active ingredients (in each tablet)
Sodium Bicarbonate 10 gr (650mg)

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:  Microcrystalline cellulose NF, Hydrogenated Vegetable oil NF

Otc - Questions

Questions or Comments? 1-866-562-4597

Other

Rev. 11/19

Manufactured for:
Rising Pharma Holdings, Inc.
2 Tower Center Blvd,
East Brunswick, NJ 08816

Manufactured by:
Aurex Laboratories LLC,
East Windsor, NJ 08520

Package Label.Principal Display Panel

———PRINCIPAL DISPLAY PANEL———

Rising®                     NDC 64980-528-10

Sodium
Bicarbonate
10 gr TABLETS, USP
Antacid

THIS PACKAGE FOR HOUSEHOLDS
WITHOUT YOUNG CHILDREN.

1000 Tablets

Label (Label)

Label (Label)

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