Aluminum Hydroxide by LLC Federal Solutions / Safecor Health, LLC ALUMINUM HYDROXIDE gel

Aluminum Hydroxide by

Drug Labeling and Warnings

Aluminum Hydroxide by is a Otc medication manufactured, distributed, or labeled by LLC Federal Solutions, Safecor Health, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient (in each 5 mL teaspoonful)
Aluminum hydroxide 320 mg

PURPOSE

Purpose
Antacid

INDICATIONS & USAGE

Uses
For the relief of

• heartburn
• acid indigestion
• sour stomach

WARNINGS

Warnings

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are taking a prescription drug.
Antacids may interact with certain prescription drugs.

WHEN USING

When using this product you may get constipated

STOP USE

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

KEEP OUT OF REACH OF CHILDREN

Keep this and all drugs out of reach of children.

DOSAGE & ADMINISTRATION

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 SAFETY INFORMATION

Other information

• store at room temperature
• protect from freezing
• keep tightly closed

INACTIVE INGREDIENT

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

QUESTIONS

Questions or comments?
Call 1-855-333-6337

SPL UNCLASSIFIED SECTION

Repackaged by:
Safecor Health LLC
317 New Boston St.
Woburn, MA 01801
Distributed by:
LLC Federal Solutions
14 NE 1st Ave.
Miami, FL 33123

PRINCIPAL DISPLAY PANEL

———PRINCIPAL DISPLAY PANEL———
NDC: 24451-091-30
ALUMINUM HYDROXIDE
GEL, USP
1920 mg / 30 mL
DELIVERS 30 mL
SUGAR FREE
MINT FLAVOR
SHAKE WELL BEFORE USING
Exp: 00/00/00 Lot # 00000

Rpk By: Safecor Health LLC
Woburn, MA 01801
Dist. By: LLC Federal Solutions
Miami, FL 33132

INGREDIENTS AND APPEARANCE

ALUMINUM HYDROXIDE 
aluminum hydroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24451-091(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)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY)
DIMETHICONE (UNII: 92RU3N3Y1O)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT (MINT FLAVOR)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24451-091-30	100 in 1 BOX
1		30 mL in 1 CUP, UNIT-DOSE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	08/12/2013

Labeler - LLC Federal Solutions (965036895)

Establishment
Name	Address	ID/FEI	Business Operations
Safecor Health, LLC		828269675	repack(24451-091)