ALMACONE- aluminum hydroxide, magnesium hydroxide, simethicone tablet, chewable

Almacone by

Drug Labeling and Warnings

Almacone by is a Otc medication manufactured, distributed, or labeled by Rugby Laboratories, Inc., Advance Pharmaceutical, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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Active ingredients (in each tablet)                          Purpose

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

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

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

PURPOSE

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Purposes

Antacid

Antigas

KEEP OUT OF REACH OF CHILDREN

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Keep out of reach of children.

INDICATIONS & USAGE

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Uses relieves

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

WARNINGS

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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.

STOP USE

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

DOSAGE & ADMINISTRATION

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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

STORAGE AND HANDLING

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

QUESTIONS

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Questions or comments ?

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

DO NOT USE

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

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM CATION - UNII:3XHB1D032B)	ALUMINUM HYDROXIDE	200 mg
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM HYDROXIDE	200 mg
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O, SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	DIMETHICONE	20 mg

Inactive Ingredients
Ingredient Name	Strength
DEXTROSE (UNII: IY9XDZ35W2)
SUCROSE (UNII: C151H8M554)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STEARIC ACID (UNII: 4ELV7Z65AP)

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	Marketing Start Date	Marketing End Date
1	NDC: 0536-3504-01	100 in 1 BOTTLE, PLASTIC

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	Business Operations
Advance Pharmaceutical, Inc.		187824339	manufacture, repack, relabel