RULOX REGULAR- aluminum hydroxide, magnesium hydroxide, dimethicone suspension 
RUGBY LABORATORIES

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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RUG RULOX

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

  • heartburn
  • sour stomach
  • acid indigestion
  • 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 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 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

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

1-800-645-2158

package Label

Rugby
NDC 0536-1945-83

compare to active ingredients in MAALOX ADVANCED REGULAR STRENGTH

pleasant tasting mint flavor

RULOX

Alumina, Magnesia and Simethicone Oral Suspension USP

non constipating antacid suspension with gas relief

for acid indigestion sour stomach and heartburn

12 fl oz (355 mL)

RUG

RULOX REGULAR 
aluminum hydroxide, magnesium hydroxide, dimethicone suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)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
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
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:0536-1945-83355 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/201303/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33101/05/201103/01/2021
Labeler - RUGBY LABORATORIES (079246066)
Registrant - GCP Laboratories (965480861)
Establishment
NameAddressID/FEIBusiness Operations
GCP Laboratories965480861manufacture(0536-1945)

Revised: 11/2020
 
RUGBY LABORATORIES