NDC | 69103-2516-5, 69103-2516-6 |
Set ID | 621fe3eb-1ef2-4272-9482-a53a7aaa32f5 |
Category | HUMAN OTC DRUG LABEL |
Packager | Provision Medical Products |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART331 |
- INDICATIONS & USAGE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- WARNINGS
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- ACTIVE INGREDIENT
- PURPOSE
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
RAZZMATAZZ ANTACID
calcium carbonate tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69103-2516 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE 420 mg Inactive Ingredients Ingredient Name Strength SUCROSE (UNII: C151H8M554) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) MAGNESIUM STEARATE (UNII: 70097M6I30) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color white (WHITE WITH GREEN FLECKS) Score no score Shape ROUND Size 12mm Flavor Imprint Code FR14 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69103-2516-5 250 in 1 CARTON 03/31/2015 1 2 in 1 PACKET; Type 0: Not a Combination Product 2 NDC:69103-2516-6 100 in 1 CARTON 03/31/2015 2 2 in 1 PACKET; 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 03/31/2015 Labeler - Provision Medical Products (036936831) Registrant - Provision Medical Products (036936831) Establishment Name Address ID/FEI Business Operations Ultraseal Corporation 085752004 pack(69103-2516) Establishment Name Address ID/FEI Business Operations ULTRAtab Laboratories, Inc. 151051757 manufacture(69103-2516)