STRATUSCARE ANTACID AND ANTIGAS REGULAR STRENGTH- dimethicone, aluminum hydroxide, and magnesium hydroxide suspension 
Stratus Pharmaceuticals

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 Regular Strength

Drug Facts

Active ingredients (in each 5 mL, 1 teaspoon)Purpose
Aluminum Hydroxide (equiv. to dried gel, USP) 200 mgAntacid
Magnesium Hydroxide 200 mgAntacid
Simethicone 20 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 16 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 85mg, 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)

Inactive ingredients

Cherry flavor, methylcellulose, methylparaben,microcrystalline cellulose, 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 58980-451-85

STRATUSCARE

Antacid &
Antigas

REGULAR 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 REGULAR STRENGTH 
dimethicone, aluminum hydroxide, and magnesium hydroxide suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58980-451
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE20 mg  in 5 mL
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE200 mg  in 5 mL
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE200 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)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58980-451-85355 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 Pharmaceuticals (789001641)

Revised: 10/2017
Document Id: e4dc681a-262f-4567-923e-351a228b8770
Set id: 67a45db2-e426-41d5-b40b-11550100d7c4
Version: 2
Effective Time: 20171025
 
Stratus Pharmaceuticals