ALUMINUM HYDROXIDE liquid

Aluminum Hydroxide by

Drug Labeling and Warnings

Aluminum Hydroxide by is a Otc medication manufactured, distributed, or labeled by Rugby Laboratories, GCP Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 5 mL teaspoonful)

Aluminum hydroxide 320 mg

Purpose

Antacid

Uses

relieves

• heartburn
• acid indigestion
• sour stomach

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

• shake well before using
• do not take more than 12 teaspoonfuls in 24 hours
• do not use the maximum dosage for more than 2 weeks
• dosage: 2 teaspoonfuls 5-6 times daily after meals and at bedtime followed by a sip of water if needed

Other information

• store at room temperature
• protect from freezing
• keep tightly closed
• TAMPER-EVIDENT: DO NOT USE IF FOIL SEAL UNDER CAP IS BROKEN OR MISSING.

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)

INGREDIENTS AND APPEARANCE

ALUMINUM HYDROXIDE 
aluminum hydroxide liquid

Product 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 final	part331	02/01/2005

Labeler - Rugby Laboratories (079246066)

Registrant - GCP Laboratories (965480861)

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