STRATUSCARE ANTACID AND ANTIGAS- dimethicone, aluminum hydroxide, and magnesium hydroxide suspension 
Stratus Pharamceuticals

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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Stratuscare Antacid & Antigas

Drug Facts

Active ingredients (in each 5 mL, 1 teaspoon)Purpose
Aluminum Hydroxide (equiv. to dried gel, USP) 400 mgAntacid
Magnesium Hydroxide 400 mgAntacid
Simethicone 40 mgAntigas

Uses

for relief

  • acid indigestion
  • heartburn
  • sour stomach
  • the 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 presently taking a prescription drug. Antacids may interact with certain prescription drugs.

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

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Directions

  • shake well before using
  • adults and children 12 years and older: take 2 - 4 tsp between meals, at bedtime or as directed by a doctor. Do not exceed 12 teaspoonfuls in a 24-hour period or use the maximum dose for more than 2 weeks unless directed by a doctor.
  • Children under 12: ask a doctor.

Other information

  • keep tightly closed
  • each teaspoon (5 mL) contains: magnesium 165mg, sodium 1mg
  • Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F)
  • Avoid freezing

Inactive ingredients

cherry flavor, methyl cellulose, methylparaben,microcrystalline cellulose, potassium citrate, propylparaben, purified water, saccharin sodium, sorbitol

Questions or comments?

Call 1-800-442-7882

Distributed by:
Stratus Pharmaceuticals Inc
12379 SW 130th Street
Miami, Florida 33186

PRINCIPAL DISPLAY PANEL - 355 mL Bottle Label

NDC 58980-452-85

STRATUSCARE

Antacid
& Antigas

MAXIMUM STRENGTH

Alumina / Magnesia /
Simethicone

Fast acting relief of:

  • Heartburn
  • Acid indigestion
  • Sour stomach & gas

Distributed by:
STRATUS
PHARMACEUTICALS INC

Cherry

12 FL OZ (355 mL)

Compare to Mylanta® active ingredients‡‡

Principal Display Panel - 355 mL Bottle Label
STRATUSCARE ANTACID AND ANTIGAS 
dimethicone, aluminum hydroxide, and magnesium hydroxide suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58980-452
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE40 mg  in 5 mL
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
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
METHYLCELLULOSE (4000 MPA.S) (UNII: MRJ667KA5E)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
POTASSIUM CITRATE (UNII: EE90ONI6FF)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58980-452-85355 mL in 1 BOTTLE; Type 0: Not a Combination Product04/26/201404/27/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33204/26/201404/27/2014
Labeler - Stratus Pharamceuticals (789001641)

Revised: 10/2017
Document Id: 815f7a52-1a03-49b8-9e8f-e8801b1e5463
Set id: 8ad3fa74-e085-439f-a7ea-105743365339
Version: 2
Effective Time: 20171024
 
Stratus Pharamceuticals