NDC | 10361-793-01 |
Set ID | 4e12e1cb-b033-076d-e054-00144ff8d46c |
Category | HUMAN OTC DRUG LABEL |
Packager | E-Z-EM, INC. |
Generic Name | |
Product Class | Anti-coagulant |
Product Number | |
Application Number | PART331 |
- DESCRIPTION
- PURPOSE
- WARNINGS
- DO NOT USE
- ASK DOCTOR
- KEEP OUT OF REACH OF CHILDREN
- ACTIVE INGREDIENT
-
DOSAGE & ADMINISTRATION
Recommended dose Maximum
recommended doseAdults
(under 60 years)One packet every 6 hours or as directed by physician Not to exceed 4 packets in 24 hours Adults
(60 years and older)One packet every 8 hours or as directed by physician Not to exceed 3 packets in 24 hours Children
(6 to 12 years)One packet every 8 hours or as directed by physician Not to exceed 3 packets in 24 hours Children
Under 6 yearsConsult physician Consult physician - HOW SUPPLIED
- INACTIVE INGREDIENT
- QUESTIONS
- INDICATIONS & USAGE
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
E-Z-GAS II
antacid/antiflatulent granule, effervescentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10361-793 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (Anhydrous Citric Acid - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID 380 mg in 1 g SODIUM BICARBONATE (UNII: 8MDF5V39QO) (Bicarbonate Ion - UNII:HN1ZRA3Q20) SODIUM BICARBONATE 550 mg in 1 g DIMETHICONE (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) DIMETHICONE 10 mg in 1 g SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (Silicon Dioxide - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 10 mg in 1 g Inactive Ingredients Ingredient Name Strength Maltodextrin (UNII: 7CVR7L4A2D) Saccharin Sodium (UNII: SB8ZUX40TY) Product Characteristics Color WHITE Score Shape Size Flavor ORANGE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10361-793-01 50 in 1 BOX 05/01/1986 1 4 g in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 05/01/1986 Labeler - E-Z-EM, INC. (002041226) Registrant - E-Z-EM, INC. (002041226) Establishment Name Address ID/FEI Business Operations Tower Laboratories Ltd 001587203 MANUFACTURE(10361-793)