Sodium bicarbonate tablet, orally disintegrating

Drug facts

Active ingredients (in each tablet)
Sodium Bicarbonate 10 gr (650mg)
Purpose
Antacid

Indications:

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

Indications & usage section

Warnings

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 maximum dosage for more than 2 weeks, except under the advice and supervision of a physician. As with any drug, if you are pregnant or nursing a baby, seek advice 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 PRODUCTWHEN OVERLY FULL FROM FOOD OR DRINK. Consult a doctor if severe stomach pain occurs after taking this product.

Drug interaction precaution:

Ask a physician or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.

Directions:

Adults -Take 1 tablet, dissolved in a glass of water, as needed. Maximum daily dose for adults up to 60 years of age is 24 tablets. Maximum daily dose for adults 60 years of age or 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 1530C (59-86F) in well-closed containers as defined in the USP.

Inactive ingredients:

Pregelatinized starch, NF and mineral oil, USP.

Otc - keep out of reach of children section

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

Ingredients and appearance - Product information

Sodium bicarbonate tablet, orally disintegrating- Sodium bicarbonate

Product information

Product Type Human OTC Drug Label Item Code (Source) NDC: 64980-182
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
Starch, corn ( UNII: O8232NY3SJ)
Mineral oil ( UNII: T5L8T28FGP)

Product Characteristics

Color WHITE Shape ROUND
Size 11 mm Score 1
Imprint Code CL;206

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 64980-182-10 1000 in 1 BOTTLE 2012/06/26

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC MONOGRAPH FINAL part331 USA 2012/06/26

Labeler - Rising Pharmaceuticals, Inc.( 041241766)

Establishment

Name ID/FEI Business Operations
Rising Pharmaceuticals, Inc. 041241766 ANALYSIS( 64980-182), LABEL( 64980-182), MANUFACTURE( 64980-182), PACK( 64980-182)

Principal display panel-1000 tablets

Rising ®NDC 64980-182-10

Sodium
Bicarbonate
10 gr TABLETS, USP
Antacid

THIS PACKAGE FOR HOUSEHOLDS
WITHOUT YOUNG CHILDREN.

1000 Tablets