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Name:Almacone
Manufacturer:Rugby Laboratories, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts for Antacid Anti-gas tablets

ALMACONE  - aluminum hydroxide, magnesium hydroxide and dimethicone 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

  • heartburn
  • acid indigestion
  • sour stomach
  • gas associated with these conditions

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Warnings

Ask a doctor before use if you have

  • kidney disease
  • a magnesium restricted diet
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 Type HUMAN OTC DRUG Item Code (Source) NDC:0536-3504
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALUMINUM HYDROXIDE (ALUMINUM CATION) ALUMINUM HYDROXIDE 200 mg
MAGNESIUM HYDROXIDE (MAGNESIUM CATION) MAGNESIUM HYDROXIDE 200 mg
DIMETHICONE (DIMETHICONE and SILICON DIOXIDE) DIMETHICONE 20 mg
Inactive Ingredients
Ingredient Name Strength
DEXTROSE  
SUCROSE  
CELLULOSE, MICROCRYSTALLINE  
STEARIC ACID  
Product Characteristics
Color white (White) Score no score
Shape ROUND (Tablet) Size 16mm
Flavor PEPPERMINT (peppermint flavor) Imprint Code 049
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0536-3504-01 100 TABLET, CHEWABLE ( TABLET) in 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part332 08/23/2010

Labeler - Rugby Laboratories, Inc. (109178264)
Registrant - Advance Pharmaceutical, Inc. (187824339)
Establishment
Name Address ID/FEI Operations
Advance Pharmaceutical, Inc. 187824339 manufacture, repack, relabel

Revised: 12/2010 Rugby Laboratories, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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