gendose - sodium bicarbonate 10 gr (650 mg) tablets (77333-827)

gendose - sodium bicarbonate 10 gr (650 mg) tablets (77333-827)
SPL v8
SPL
SPL Set ID f6e4af32-d567-2b02-e053-6394a90aa7a0
Route
oral
Published
Effective Date 2023-03-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
sodium cation (650 mg)
Inactive Ingredients
magnesium stearate microcrystalline cellulose stearic acid

Identifiers & Packaging

Pill Appearance
Imprint: S65 Shape: round Color: white Size: 11 mm Score: 1
Marketing Status
otc monograph drug active Since 2023-03-14

Purpose

Antacid

Description

Sodium bicarbonate 10 gr. (650 mg)


Medication Information

Warnings
  • DO NOT TAKE MORE THAN 24 TABLETS FOR ADULTS UP TO 60 YEARS OF AGE (0R 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.
  • 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.
Active Ingredient

Sodium bicarbonate 10 gr. (650 mg)

Uses

Relieves

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

Antacid

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)
Inactive Ingredients

MICROCRYSTALLINE CELLULOSE, STEARIC ACID, MAGNESIUM STEARATE

Description

Sodium bicarbonate 10 gr. (650 mg)

Section 50565-1
  • KEEP OUT OF REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.
Section 51945-4


Structured Label Content

Warnings (WARNINGS)
  • DO NOT TAKE MORE THAN 24 TABLETS FOR ADULTS UP TO 60 YEARS OF AGE (0R 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.
  • 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.
Active Ingredient (Active ingredient (in each tablet))

Sodium bicarbonate 10 gr. (650 mg)

Uses

Relieves

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

Antacid

Directions (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 (OTHER INFORMATION)
  • each tablet contains : sodium 178 mg (7.74 mEq)
  • store at room temperature 15°-30°C (59°-86°F)
Inactive Ingredients (INACTIVE INGREDIENTS)

MICROCRYSTALLINE CELLULOSE, STEARIC ACID, MAGNESIUM STEARATE

Section 50565-1 (50565-1)
  • KEEP OUT OF REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.
Section 51945-4 (51945-4)


Advanced Ingredient Data


Raw Label Data

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