NDC | 51467-100-01 |
Set ID | 8a1783d3-421b-481f-8517-db82cb837b24 |
Category | HUMAN OTC DRUG LABEL |
Packager | FORTUNE PHARMACAL COMPANY LIMITED |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART331 |
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
MAGSIL ANTACID (LEMON MINT)
aluminum hydroxide dried gel, magnesium hydroxide, and simethicone tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51467-100 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE 200 mg MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE 200 mg DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 21 mg Inactive Ingredients Ingredient Name Strength ASPARTAME (UNII: Z0H242BBR1) STARCH, CORN (UNII: O8232NY3SJ) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) POVIDONE K30 (UNII: U725QWY32X) Product Characteristics Color yellow Score no score Shape ROUND Size 16mm Flavor LEMON, MINT Imprint Code MAGSIL;FORTUNE Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51467-100-01 4 in 1 BOX 09/22/2017 1 6 in 1 BLISTER PACK; 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 09/20/2017 Labeler - FORTUNE PHARMACAL COMPANY LIMITED (686280561) Establishment Name Address ID/FEI Business Operations FORTUNE PHARMACAL COMPANY LIMITED 686280561 manufacture(51467-100)