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

OTC - ACTIVE INGREDIENT

Active ingredients (in each tablet) Purpose

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

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

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

OTC - PURPOSE

Purposes

Antacid

Antigas

OTC - KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

INDICATIONS & USAGE

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.

OTC - 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.

DOSAGE & ADMINISTRATION

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 AND HANDLING

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

OTC - QUESTIONS

Questions or comments ?

call 1-800-645-2158

OTC - DO NOT USE

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

INACTIVE INGREDIENT

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

DRUG: Almacone

GENERIC: Aluminum hydroxide, Magnesium hydroxide, Simethicone

DOSAGE: TABLET, CHEWABLE

ADMINSTRATION: ORAL

NDC: 61786-094-10

ACTIVE INGREDIENT(S):

ALUMINUM HYDROXIDE 200mg in 1
DIMETHICONE 25mg in 1
MAGNESIUM HYDROXIDE 200mg in 1

INACTIVE INGREDIENT(S):

DEXTROSE
MALTODEXTRIN
MANNITOL
MAGNESIUM STEARATE
SACCHARIN SODIUM
SORBITOL
STARCH, POTATO
GLYCERIN
ANHYDROUS CITRIC ACID
CELLULOSE, MICROCRYSTALLINE
STEARIC ACID
D&C YELLOW NO. 10
D&C RED NO. 30
STARCH, CORN
SUCROSE

COLOR: yellow

FLAVOR: LEMON

SHAPE: ROUND

SCORE: No score

SIZE: 16 mm

IMPRINT: G152

PACKAGING: 6 in 1 BOTTLE

MM1

MM2

ALMACONE
aluminum hydroxide, magnesium hydroxide, simethicone tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61786-094(NDC:0536-1011)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0)	ALUMINUM HYDROXIDE	200 mg
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	25 mg
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM HYDROXIDE	200 mg

Ingredient Name	Strength
Inactive Ingredients
DEXTROSE (UNII: IY9XDZ35W2)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MANNITOL (UNII: 3OWL53L36A)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
STARCH, POTATO (UNII: 8I089SAH3T)
GLYCERIN (UNII: PDC6A3C0OX)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STEARIC ACID (UNII: 4ELV7Z65AP)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
D&C RED NO. 30 (UNII: 2S42T2808B)
STARCH, CORN (UNII: O8232NY3SJ)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	yellow	Score	no score
Shape	ROUND (TABLET, CHEWABLE)	Size	16mm
Flavor	LEMON	Imprint Code	G152
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:61786-094-10	6 in 1 BOTTLE; Type 0: Not a Combination Product	11/12/2014	01/21/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part332	11/12/2014	01/21/2016

Labeler - REMEDYREPACK INC. (829572556)

Revised: 2/2017

Document Id: 48c15054-d538-4fa4-e054-00144ff88e88

Set id: 13b07d22-a15e-4aa7-9500-87be4f5b4898

Version: 2

Effective Time: 20170217

REMEDYREPACK INC.