Sodium bicarbonate tablet

Drug facts

Active Ingredient (in each tablet)

Sodium bicarbonate 10 gr (650 mg)

Otc - purpose section

Antacid

Indications:

Relieves:

  • acid indigestion
  • heartburn
  • sour stomach
  • upset stomach

associated with these symptoms

Warnings

Otc - do not use section

Do not use this product if you are on a sodium-restricted diet unless directed by a doctor. 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.

Otc - pregnancy or breast feeding section

As with any drug, if you are pregnant or nursing a baby, seek advise of a health professional before using this product.

Stomach warning:

TO AVOID SERIOUS INJURY, DO NOT TAKE UNTIL TABLET IS COMPLETELY DISSOLVED. IT IS VERY IMPORTANT NOT TO TAKE THIS PRODUCT WHEN OVERLY FULL FROM FOOD OR DRINK. Consult a doctor if severe stomach pain occurs after taking this product.

Drug interaction precaution:

Antacids may interact with certain prescription drugs. If you are presently taking a prescription drug, do not take this product without checking with your physician or other health professional.

Directions:

  • Adults - Take 1 tablet, dissolved in a glass of water, as needed.
  • Maximum daily dose for adults upto 60 years of age is 24 tablets.
  • Maximum daily dose for adults 60 years of age and older is 12 tablets.
  • Dissolve completely in water before drinking.
  • DO NOT EXCEED RECOMMENDED DOSE. Not recommended for children.

Other information:

  • each tablet contains: sodium 178 mg (7.74 meq)
  • store at room temperature 15 - 30 C (59 - 86 F) in well-closed containers as defined in the USP.

Inactive ingredients:

Pregelatinized starch, NF and mieral oil, USP.

Otc - keep out of reach of children section

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

Overdosage section

In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

Ingredients and appearance - Product information

Sodium bicarbonate tablet- Sodium bicarbonate

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 52682-206
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Sodium bicarbonate ( UNII: 8MDF5V39QO)( Bicarbonate ion - UNII: HN1ZRA3Q20 ) 650 mgin 1

Inactive Ingredients

Ingredient Name Code
Mineral oil ( UNII: T5L8T28FGP)
Starch, corn ( UNII: O8232NY3SJ)

Product Characteristics

Color WHITE (White) Score 2
Shape ROUND (round) Size 11 mm
Imprint Code CL;206

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph final part331 USA

Labeler - Ingenus Pharmaceuticals NJ, LLC( 964680206)

Establishment

Name ID/FEI Business Operations
Ingenus Pharmaceuticals NJ, LLC 964680206 manufacture( 52682-206), analysis( 52682-206), label( 52682-206), pack( 52682-206)

Package label.principal display panel

ingenus

NDC 52682-206-04

SODIUM BICARBONATE

10 gr (650 mg)

Antacid

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN.

1000 Tablets

Mfd. by Ingenus Pharmaceuticals NJ, LLC

Fairfield, NJ 07004