ROBAFEN COUGH NON-DROWSY FORMULA- 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 44-661-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 (1-800-222-1222) 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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • avoid excessive heat above 40ºC (104ºF)
  • protect from light
  • see bottle for lot number and expiration date

Inactive ingredients

edible white ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol

Questions or comments?

1-800-645-2158

Principal display panel

Rugby®

NDC 0536-1068-34

Compare to the active ingredient in Robitussin® Long-Acting CoughGels®*

Non-Drowsy Formula
ROBAFEN® COUGH
LIQUIDGELS

Dextromethorphan HBr, USP 15 mg
Cough Suppressant

8-Hour Cough Relief

Easy-to-Swallow
Liquid-Filled
Capsules

20
Liquidgels
(Liquid-Filled
Capsules) 

Distributed by:
Rugby Laboratories
17177 N Laurel Park Drive
Suite 233
Livonia, MI 48152
www.rugbylaboratories.com
R-17
Rev. 05/19
Re-Order No. 370416

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

*This product is not manufactured or distributed by Wyeth LLC, owner of the registered trademark Robitussin® Long-Acting CoughGels®.

50844   REV0319C66109

Product of China

Packaged and Quality Assured in the USA

Rugby 44-661

Rugby 44-661

ROBAFEN COUGH  NON-DROWSY FORMULA
dextromethorphan hbr capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1068
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)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
Colorred (clear) Scoreno score
ShapeOVALSize10mm
FlavorImprint Code 661
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1068-341 in 1 PACKAGE03/01/201510/31/2022
120 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/01/201510/31/2022
Labeler - Rugby Laboratories (079246066)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464pack(0536-1068)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088pack(0536-1068)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305pack(0536-1068)

Revised: 8/2023
Document Id: 9638e3dd-f39e-4c7c-925d-476a4969c200
Set id: 206fff2b-1b9d-4b7f-bcef-b055825d4fe7
Version: 11
Effective Time: 20230814
 
Rugby Laboratories