ALUMINUM HYDROXIDE- aluminum hydroxide liquid 
Rugby Laboratories

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Rugby aluminum hydroxide

Active ingredient (in each 5 mL teaspoonful)

Aluminum hydroxide 320 mg

Purpose

Antacid

Uses

relieves

Warnings

Ask a doctor or pharmacist before use if you are taking a prescription drug.

Antacids may interact with certain prescription drugs.
When using this product you may get constipated

Stop use and ask a doctor if symptoms last more than 2 weeks

Keep out of reach of children.

Directions

Other information

Inactive ingredients

benzyl alcohol, butylparaben, flavor, glycerin, hydroxyethylcellulose, propylparaben, purified water, saccharin sodium, simethicone emulsion, sorbitol solution

Questions or comments?

1-800-645-2158

package Label

compare to the active ingredient in AMPHOJEL

Rugby

NDC 0536-0091-85
MINT FLAVOR

Aluminum 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)

rug al

ALUMINUM HYDROXIDE 
aluminum hydroxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-0091
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE320 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorMINT (mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-0091-85473 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33102/01/2005
Labeler - Rugby Laboratories (079246066)
Registrant - GCP Laboratories (965480861)
Establishment
NameAddressID/FEIBusiness Operations
GCP Laboratories965480861manufacture(0536-0091)

Revised: 11/2017
Document Id: 5e0c3967-d2b0-4acb-e053-2a91aa0af2bf
Set id: 27c574a5-1fe0-4973-9a31-9beb4fc6ec46
Version: 2
Effective Time: 20171115
 
Rugby Laboratories