Label: ALUMINUM HYDROXIDE liquid
- NDC Code(s): 0536-0091-85
- Packager: Rugby Laboratories
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 2, 2023
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- Active ingredient (in each 5 mL teaspoonful)
- Purpose
- Uses
- Warnings
- Directions
- Other information
- Inactive ingredients
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package Label
compare to the active ingredient in AMPHOJEL
Rugby
NDC 0536-0091-85
MINT FLAVORAluminum Hydroxide Gel, USP
ANTACID
SUGAR FREE
This is a bulk package. Dispense contents with a child-resistant closure in a tight, light-resistant container as defined in the USP.
Rugby Laboratories, INC. is not affiliated with the owner of the trademark Amphojel.
16 fl oz (473 mL) -
INGREDIENTS AND APPEARANCE
ALUMINUM HYDROXIDE
aluminum hydroxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-0091 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE 320 mg in 5 mL Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL (UNII: LKG8494WBH) BUTYLPARABEN (UNII: 3QPI1U3FV8) GLYCERIN (UNII: PDC6A3C0OX) HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45) DIMETHICONE (UNII: 92RU3N3Y1O) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBITOL (UNII: 506T60A25R) Product Characteristics Color Score Shape Size Flavor MINT (mint) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0536-0091-85 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/01/2017 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)