NDC Code(s) : 0536-0091-85
Packager : Rugby Laboratories

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Aluminum Hydroxidealuminum hydroxide LIQUID
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-0091
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
(ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) 		ALUMINUM HYDROXIDE320 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL(UNII: LKG8494WBH)
BUTYLPARABEN(UNII: 3QPI1U3FV8)
GLYCERIN(UNII: PDC6A3C0OX)
HYDROXYETHYLCELLULOSE(UNII: T4V6TWG28D)
DIMETHICONE(UNII: 92RU3N3Y1O)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
WATER(UNII: 059QF0KO0R)
SACCHARIN SODIUM(UNII: SB8ZUX40TY)
SORBITOL SOLUTION(UNII: 8KW3E207O2)
Product Characteristics
Color Score
Shape Size
Flavor MINT Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0536-0091-85473 mL in 1 BOTTLE Type 0: Not a Combination Product07/01/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M001 02/01/2005

LABELER - Rugby Laboratories(079246066)

REGISTRANT - GCP Laboratories(965480861)

Establishment
Name Address ID/FEI Business Operations
GCP Laboratories 965480861 manufacture(0536-0091)

PRINCIPAL DISPLAY PANEL

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