ALMACONE DOUBLE STRENGTH- aluminum hydroxide, magnesium hydroxide, dimethicone suspension 
REMEDYREPACK INC.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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RUG ALMACONE DS

Active ingredients (in each 5 mL teaspoonful)

Aluminum hydroxide 400 mg (equivalent to dried gel, USP)
Magnesium hydroxide 400 mg
Simethicone 40mg

Purposes

Antacid
Antigas

Uses

relieves

  • heartburn
  • sour stomach
  • acid indigestion
  • symptoms 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 taking a prescription drug.
Antacids may interact with certain prescription drugs.
Stop use and ask a doctor if symptoms last more than 2 weeks

Keep out of reach of children.

Directions

  • shake well before use
  • adults and children 12 years of age and older: take 2 to 4 teaspoonfuls between meals, at bedtime, or as directed by a doctor
  • do not take more than 12 teaspoonfuls in 24 hours or use the maximum dosage for more than 2 weeks
  • children under 12 years: ask a doctor

Other information

  • each 5 mL teaspoonful contains: magnesium 165 mg, sodium 5 mg
  • store at room temperature
  • protect from freezing
  • keep tightly closed

Inactive ingredients

benzyl alcohol, butylparaben, carboxymethylcellulose sodium, flavor (contains alcohol), hypromellose, microcrystalline cellulose, propylparaben, purified water, saccharin sodium, sorbitol solution

Questions or comments?

1-800-645-2158

DRUG: ALMACONE DOUBLE STRENGTH

GENERIC: aluminum hydroxide, magnesium hydroxide, dimethicone

DOSAGE: SUSPENSION

ADMINSTRATION: ORAL

NDC: 70518-1973-0

NDC: 70518-1973-1

FLAVOR: LEMON

PACKAGING: 20 mL in 1 CUP, UNIT-DOSE

OUTER PACKAGING: 10 in 1 BOX

ACTIVE INGREDIENT(S):

  • MAGNESIUM HYDROXIDE 400mg in 5mL
  • DIMETHICONE 40mg in 5mL
  • ALUMINUM HYDROXIDE 400mg in 5mL

INACTIVE INGREDIENT(S):

  • BENZYL ALCOHOL
  • BUTYLPARABEN
  • CARBOXYMETHYLCELLULOSE SODIUM
  • HYPROMELLOSES
  • CELLULOSE, MICROCRYSTALLINE
  • PROPYLPARABEN
  • WATER
  • SACCHARIN SODIUM
  • SORBITOL

MM1

MM2

ALMACONE DOUBLE STRENGTH 
aluminum hydroxide, magnesium hydroxide, dimethicone suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70518-1973(NDC:0536-0015)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE400 mg  in 5 mL
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE400 mg  in 5 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE40 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorLEMON (lemon) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70518-1973-010 in 1 BOX03/21/201910/13/2023
1NDC:70518-1973-120 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/21/201910/13/2023
Labeler - REMEDYREPACK INC. (829572556)

Revised: 5/2023
Document Id: ef68d0d2-181c-35b9-e053-2995a90a4b24
Set id: ac1bb713-6915-4e40-84dc-df0fa1f01fab
Version: 7
Effective Time: 20230509
 
REMEDYREPACK INC.