ANTACID - aluminum hydroxide, magnesium hydroxide, simethicone liquid 
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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Rugby Regular Strength Antacid Liquid

ACTIVE INGREDIENTS (in each 10 mL )

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

PURPOSE

Antacid
Antacid
Antigas

USE(S)

relieves:


WARNINGS

Do not take more than 80 mL in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor.

ASK A DOCTOR BEFORE USE IF YOU HAVE

ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE 

STOP USE AND ASK DOCTOR

if symptoms last more than two weeks

KEEP OUT OF REACH OF CHILDREN

.

DIRECTIONS

OTHER INFORMATION

INACTIVE INGREDIENTS

ethyl alcohol, flavor, glycerin, hydroxyethyl cellulose, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, simethicone emulsion, sorbitol

PRINCIPAL DISPLAY PANEL

Rugby

NDC 0536-1293-83

Regular Strength
Antacid Liquid

Aluminum hydroxide, 400 mg
Magnesium hydroxide, 400 mg
Simethicone, 40 mg

    

Antacid and Antigas
Original Flavor

 

Relief of:

Heartburn

Acid Indigestion

Sour Stomach

Pressure & Bloating


 
12 FL OZ (355 mL)
Alcohol content 0.2% v/v


80




ANTACID 
aluminum hydroxide, magnesium hydroxide, simethicone liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1293
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE400 mg  in 10 mL
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE400 mg  in 10 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE40 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1293-83355 mL in 1 BOTTLE; Type 0: Not a Combination Product06/02/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33106/02/2021
Labeler - Rugby Laboratories (079246066)
Establishment
NameAddressID/FEIBusiness Operations
Guardian Drug Company119210276MANUFACTURE(0536-1293)

Revised: 6/2021
Document Id: ec4ea84e-ce4c-4acd-b306-75df725abd6d
Set id: bd58baac-5790-455a-9c77-236680992579
Version: 2
Effective Time: 20210602
 
Rugby Laboratories