ALMACONE - aluminum hydroxide, magnesium hydroxide, simethicone tablet, chewable 
Rugby Laboratories, Inc.

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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Drug Facts for Antacid Anti-gas tablets

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Active ingredients (in each tablet)                          Purpose

Aluminum Hydroxide (dried gel) 200mg ...........        Antacid

Magnesium Hydroxide 200mg ............                        Antacid

Simethicone 20 mg ..............                                        Antigas


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Purposes

Antacid

Antigas

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Keep out of reach of children.

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Uses relieves

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Warnings

Ask a doctor before use if you have

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

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

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dosage: chew 2 - 4 tablets between meals and at bedtime.

do not take more than 24 tablets in a 24 hour period.

do not use the maximum dose for more than 2 weeks.

each tablet contains: magnesium 82 mg


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store between 15 o - 30 o C ( 59o  - 86o F ) 

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Questions or comments ?

call 1-800-645-2158, 9am - 5pm ET, Monday - Friday

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TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

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Inactive ingredients: dextrose, dipac sugar, microcrystalline cellulose, peppermint flavor, stearic acid

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ALMACONE 
aluminum hydroxide, magnesium hydroxide, simethicone tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-3504
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM CATION - UNII:3XHB1D032B) ALUMINUM HYDROXIDE200 mg
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE200 mg
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O, SILICON DIOXIDE - UNII:ETJ7Z6XBU4) DIMETHICONE20 mg
Inactive Ingredients
Ingredient NameStrength
DEXTROSE (UNII: IY9XDZ35W2)  
SUCROSE (UNII: C151H8M554)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
Colorwhite (White) Scoreno score
ShapeROUND (Tablet) Size16mm
FlavorPEPPERMINT (peppermint flavor) Imprint Code 049
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-3504-01100 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33208/23/2010
Labeler - Rugby Laboratories, Inc. (109178264)
Registrant - Advance Pharmaceutical, Inc. (187824339)
Establishment
NameAddressID/FEIBusiness Operations
Advance Pharmaceutical, Inc.187824339manufacture, repack, relabel

Revised: 12/2010
Document Id: 9830a852-c0a7-4ac9-9848-4cf86dd07013
Set id: c45c2afe-9048-441f-9f6c-9c43e29065da
Version: 2
Effective Time: 20101201
 
Rugby Laboratories, Inc.