Sodium Bicarbonate 10 Gr. (650 Mg) Tablet
FDA Label NDC 77333-829

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Gendose Pharmaceuticals, Llc for the product Sodium Bicarbonate 10 Gr. (650 Mg) (NDC 77333-829). 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 tablet), purpose, uses, otc - do not use, otc - ask doctor/pharmacist, otc - stop use, otc - pregnancy or breast feeding, 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 Tablet)

Sodium Bicarbonate 10 gr. (650 mg)

Purpose

Antacid

Uses

relieves

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

Otc - Do Not Use

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 maximum dosage for more than 2 weeks, except under the advice and supervision of a physician. 

Otc - Ask Doctor/Pharmacist

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.

Otc - Stop Use

Stop use and ask a doctorif symptoms last more than 2 weeks.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast feeding, ask a health professional before use.

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center  (1-800-222-1222) immediately.

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

Other Information

  • each tablet contains:sodium 178 mg (7.74 mEq)
  • store at room temperature 15°-30°C (59°-86°F)

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