ALMACONE- aluminum hydroxide, magnesium hydroxide, simethicone tablet, chewable 
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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Drug Facts for Antacid Anti-gas tablets

Active Ingredients

Active ingredients (in each tablet)                                   Purpose

Aluminum Hydroxide (equiv. to dried gel, USP) 200mg ......... Antacid

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

Simethicone 25 mg ..............                                                   Antigas

Purpose

Purposes

Antacid

Antigas

Keep out of reach of children

Keep out of reach of children.

Uses

Uses relieves

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

Warnings

Ask a doctor ​before use if you have

kidney disease
a magnesium restricted

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

Stop use

Do not take more than 16 tablets in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor.

Directions

Dosage: chew 1 - 4 tablets 4 times a day or as directed by a doctor.

do not take more than 16 tablets in a 24 hour period.

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

each tablet contains: magnesium 85 mg

Storage

Store at room temperature between 15 o - 30 o C ( 59o  - 86o F )
Keep tightly closed and dry.

Questions or comments?

Questions or comments ?

call 1-800-645-2158

Do not use

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

Inactive ingredients

citric acid anhydrous, corn starch, D&C red 30 lake, D&C yellow 10 lake, destrose, flavors, glycerin, magnesium stearate, maltodextrin, mannitol, pregelatinized starch, saccharin sodium, sorbitol, sugar

Principal display panel

Almacone Chewable Antacid Antigas

ALMACONE 
aluminum hydroxide, magnesium hydroxide, simethicone tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1011
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE200 mg
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE200 mg
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE25 mg
Inactive Ingredients
Ingredient NameStrength
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
STARCH, CORN (UNII: O8232NY3SJ)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
GLYCERIN (UNII: PDC6A3C0OX)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MANNITOL (UNII: 3OWL53L36A)  
STARCH, POTATO (UNII: 8I089SAH3T)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
SUCROSE (UNII: C151H8M554)  
Product Characteristics
ColorYELLOW (White) Scoreno score
ShapeROUND (Tablet) Size16mm
FlavorLEMON (peppermint flavor) Imprint Code G152
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1011-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/23/201408/30/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33201/23/201408/30/2019
Labeler - Rugby Laboratories (079246066)
Establishment
NameAddressID/FEIBusiness Operations
Guardian Drug Company119210276manufacture(0536-1011)

Revised: 9/2019
 
Rugby Laboratories