ALUMINUM HYDROXIDE - aluminum hydroxide gel 
LLC Federal Solutions

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

Purpose
Antacid

Uses
For the relief of

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 this and all drugs 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?
Call 1-855-333-6337

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———
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

product label

ALUMINUM HYDROXIDE 
aluminum hydroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24451-091(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)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMINT (MINT FLAVOR) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24451-091-30100 in 1 BOX
130 mL in 1 CUP, UNIT-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33108/12/2013
Labeler - LLC Federal Solutions (965036895)
Establishment
NameAddressID/FEIBusiness Operations
Safecor Health, LLC828269675repack(24451-091)

Revised: 8/2013
Document Id: 18de8a4b-df09-498a-ab6b-df914a59e48a
Set id: af9b799f-69c5-401c-9c43-a97b23384cc2
Version: 1
Effective Time: 20130812
 
LLC Federal Solutions