RUGBY ALMACONE- aluminum hydroxide, magnesium hydroxide, simethicone suspension 
Rugby Laboratories

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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Rugby Laboratories Almacone® Drug Facts

Active ingredients (in each 10 mL)

Aluminum hydroxide (equiv. to dried gel, USP) 400 mg

Magnesium hydroxide 400 mg

Simethicone 40 mg

Purposes

Antacid

Antigas

Uses

relieves

heartburn
acid indigestion
sour stomach
upset stomach due to these symptoms
pressure and bloating commonly referred to as gas

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

presently taking a prescription drug. Antacids may interact with certain prescription drugs.

When using this product

do not exceed 120 mL in a 24-hour period, or use the maximum dosage for more than 2 weeks, unless directed by a doctor

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

shake well before use
measure with dosing cup provided
adults and children 12 years and over: 10 mL – 20 mL between meals, at bedtime or as directed by a doctor
do not take more than 120 mL in any 24 hour period
do not use the maximum dosage for more than 2 weeks
children under 12 years: ask a doctor
mL = milliliter

Other information

each 10 mL contains: magnesium 175 mg
does not meet USP requirements for preservative effectiveness
store at 20-25°C (68-77°F), do not freeze

Inactive ingredients

butylparaben, flavor, hypromellose, microcrystalline cellulose and carboxymethylcellulose sodium, peppermint oil, propylparaben, purified water, simethicone emulsion, sorbitol, sorbitol solution

Questions or comments?

1-800-645-2158

Principal Display Panel

Regular Strength

Almacone®

Aluminum Hydroxide

Magnesium Hydroxide, Simethicone

ANTACID

ANTIGAS

VERY LOW SODIUM

12 fl oz (355 mL)

ALCOHOL 0.2%

almacone image
RUGBY ALMACONE 
aluminum hydroxide, magnesium hydroxide, simethicone suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1185
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE400 mg  in 10 mL
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE400 mg  in 10 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE40 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorWHITE (opaque) Score    
ShapeSize
FlavorMINT, LEMONImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1185-83355 mL in 1 BOTTLE; Type 0: Not a Combination Product12/19/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33112/19/2018
Labeler - Rugby Laboratories (079246066)

Revised: 1/2019
Document Id: 7f06d5b8-e781-416a-bcec-44d9650cac0c
Set id: 7f06d5b8-e781-416a-bcec-44d9650cac0c
Version: 1
Effective Time: 20190107
 
Rugby Laboratories