RULOX REGULAR  - aluminum hydroxide, magnesium hydroxide, dimethicone suspension 
TYA 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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Active ingredients (in each 5 mL teaspoonful)

Aluminum hydroxide 200 mg (equivalent to dried gel, USP) Magnesium hydroxide 200 mg Simethicone 20mg

Purposes

Antacid Antigas


Uses

relieves

Warnings

• kidney disease • a magnesium-restricted diet taking a prescription drug. Antacids may interact with certain prescription drugs. symptoms last more than 2 weeks Ask a doctor before use if you have


Ask a doctor or pharmacist before use if you are



Stop use and ask a doctor if

Keep out of reach of children.

Directions

• shake well before use • adults and children 12 years and older: take 2 to 4 teaspoonfuls four times a day, or as directed by a doctor • do not take more than 16 teaspoonfuls in 24 hours or use the maximum dosage for more than 2 weeks • children under 12 years: ask a doctor



Other information

• magnesium 85 mg, sodium 1 mg • store at room temperature each 5 mL teaspoonful contains:

• protect from freezing  • keep tightly closed

TAMPER-EVIDENT: Do not use if breakaway band on bottle is missing or broken.

Inactive ingredients

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

Questions or comments?

Call 1-800-645-2158, 9am -5 pm ET, Monday-Friday

RULOX REGULAR (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION

Label Image
RULOX REGULAR  
aluminum hydroxide, magnesium hydroxide, dimethicone suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64725-1945(NDC:0536-1945)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
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
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE20 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
FlavorMINT (mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64725-1945-1355 mL in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33101/05/2011
Labeler - TYA Pharmaceuticals (938389038)
Registrant - TYA Pharmaceuticals (938389038)
Establishment
NameAddressID/FEIBusiness Operations
TYA Pharmaceuticals938389038RELABEL(64725-1945) , REPACK(64725-1945)

Revised: 7/2012
Document Id: 123b4dce-02c1-4b3b-a688-cac53b0d7a94
Set id: b95edae9-58b8-4c5f-82f4-28a4599f1907
Version: 2
Effective Time: 20120717
 
TYA Pharmaceuticals