ROBAFEN COUGH NON-DROWSY FORMULA- dextromethorphan hbr capsule, liquid filled

Robafen Cough by

Drug Labeling and Warnings

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

Drug Details [pdf]

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
31778 Enterprise Drive
Livonia, MI 48150
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   REV0319B66109

Product of China

Packaged and
Quality Assured
in the USA

44-661

INGREDIENTS AND APPEARANCE

ROBAFEN COUGH  NON-DROWSY FORMULA
dextromethorphan hbr capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1068
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	RED (clear)	Score	no score
Shape	OVAL	Size	10mm
Flavor		Imprint Code	661
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-1068-34	1 in 1 PACKAGE	03/01/2015
1		20 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	03/01/2015

Labeler - Rugby Laboratories (079246066)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(0536-1068)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(0536-1068)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(0536-1068)