DEXTROMETHORPHAN HBR 15 MG LIQUID GELS- 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.

----------

Dextromethorphan HBr USP 15 mg Liquid Gels

Drug Facts

Active ingredient (in each softgel)

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 can be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Directions

• do not take more than 8 softgels 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 older
 take 2 softgels
every 6 to 8
hours, as needed
children under
12 years
 do not use

Other information

• store at 20°-25°C(68°-77°F)
• avoid excessive heat above 40°C(104°F)
• protect from light

Inactive ingredients

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

Questions or comments?

1-800-645-2158

Rugby®

Compare to the active ingredient in Robitussin® CoughGels®*

ADULT

Relieves:
Cough for up to 8 hours
Non-Drowsy

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

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

Distributed by:
RUGBY® LABORATORIES
Livonia, MI 48152
www.rugbylaboratories.com

Product of UAE

Packaged and Quality
Assured in the USA

Packaging

Dextro1

DEXTROMETHORPHAN HBR 15 MG LIQUID GELS 
dextromethorphan hbr capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1334
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)  
SORBITOL (UNII: 506T60A25R)  
SORBITAN (UNII: 6O92ICV9RU)  
Product Characteristics
ColorredScoreno score
ShapeOVALSize13mm
FlavorImprint Code 778
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1334-3420 in 1 BOTTLE; Type 0: Not a Combination Product09/04/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/04/2021
Labeler - RUGBY LABORATORIES (079246066)

Revised: 7/2023
Document Id: 50320858-6b9c-416f-b677-3f242cfd305c
Set id: cf3cc387-6642-43fd-999d-688fdaf65d4f
Version: 3
Effective Time: 20230725
 
RUGBY LABORATORIES