Dextromethorphan HBr by Rugby Laboratories / LNK International, Inc. Rugby 44-732-Delisted

Dextromethorphan HBr by

Drug Labeling and Warnings

Dextromethorphan HBr by is a Otc medication manufactured, distributed, or labeled by Rugby Laboratories, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DEXTROMETHORPHAN HBR- dextromethorphan hbr capsule, liquid filled 
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 44-732-Delisted

Active ingredient (in each liquid-filled capsule)

Dextromethorphan HBr, USP 15 mg

Purpose

Cough suppressant

Use

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold

Warnings

Do not use

if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

  • a cough that occurs with too much phlegm (mucus)
  • a cough that lasts or is chronic as occurs with smoking, asthma, or emphysema

Stop use and ask a doctor if

cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

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 right away.

Directions

  • do not take more than 8 capsules in any 24-hour period
  • this adult product is not intended for use in children under 12 years of age
  • adults and children 12 years and over: take 2 capsules every 6 to 8 hours, as needed
  • children under 12 years: do not use

Other information

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • protect from light, heat and moisture
  • see bottle for lot number and expiration date

Inactive ingredients

FD&C blue #1, FD&C red #40, gelatin, glycerin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, povidone, propyl gallate, propylene glycol, purified water, sorbitol sorbitan solution, white ink

Questions or comments?

1-800-645-2158

Principal display panel

Rugby®

NDC: 0536-1323-34

Compare to the
active ingredient in
Robitussin® CoughGels®*

Dextromethorphan HBr
USP
15 mg

Cough Suppressant

Up to 8 Hours
For Ages 12 and Over
Non-Drowsy

20 Liquidgels
(Liquid Filled Capsules)

Actual Size

Distributed by:
RUGBY® LABORATORIES
17177 N Laurel Park Drive
Suite 233
Livonia, MI 48152
www.rugbylaboratories.com

Rev. 10/20

PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org

*This product is
not manufactured
or distributed by
PF Consumer Healthcare 1 LLC,
owner of the
registered
trademark Robitussin®
CoughGels®.

50844 ORG012073209

Product of Dubai
Packaged and
Quality Assured
in the USA

KEEP OUTER
PACKAGE FOR
COMPLETE
PRODUCT
INFORMATION

TAMPER EVIDENT: DO NOT USE IF
IMPRINTED SAFETY SEAL UNDER
CAP IS BROKEN OR MISSING

Rev. 10/20   R-17   Re-Order No. 371074

Rugby 44-732

Rugby 44-732

DEXTROMETHORPHAN HBR 
dextromethorphan hbr capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0536-1323
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
PROPYL GALLATE (UNII: 8D4SNN7V92)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITAN (UNII: 6O92ICV9RU)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
Colorred (clear) Scoreno score
ShapeOVALSize14mm
FlavorImprint Code 732
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0536-1323-341 in 1 PACKAGE10/30/202012/03/2023
120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/30/202012/03/2023
Labeler - Rugby Laboratories (079246066)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464pack(0536-1323)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305pack(0536-1323)

Revised: 6/2023
 

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