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NDC 00536-1068-34 Robafen Cough 15 mg/1 Details

Robafen Cough 15 mg/1

Robafen Cough is a ORAL CAPSULE, LIQUID FILLED in the HUMAN OTC DRUG category. It is labeled and distributed by Rugby Laboratories. The primary component is DEXTROMETHORPHAN HYDROBROMIDE.

MedlinePlus Drug Summary

Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.

Related Packages: 00536-1068-34
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dextromethorphan

Product Information

NDC	00536-1068
Product ID	0536-1068_41f3d525-5f6a-4b3b-bf16-d5fb8efe9625
Associated GPIs	43102030500110
GCN Sequence Number	004622
GCN Sequence Number Description	dextromethorphan HBr CAPSULE 15 MG ORAL
HIC3	H6C
HIC3 Description	ANTITUSSIVES, NON-OPIOID
GCN	17770
HICL Sequence Number	001925
HICL Sequence Number Description	DEXTROMETHORPHAN HBR
Brand/Generic	Generic
Proprietary Name	Robafen Cough
Proprietary Name Suffix	Non-Drowsy Formula
Non-Proprietary Name	Dextromethorphan HBr
Product Type	HUMAN OTC DRUG
Dosage Form	CAPSULE, LIQUID FILLED
Route	ORAL
Active Ingredient Strength	15
Active Ingredient Units	mg/1
Substance Name	DEXTROMETHORPHAN HYDROBROMIDE
Labeler Name	Rugby Laboratories
Pharmaceutical Class	Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2023-12-31

Package

Package Images

NDC 00536-1068-34 (00536106834)

Pricing Information	N/A
NDC Package Code	0536-1068-34
Billing NDC	00536106834
Package	1 BOTTLE in 1 PACKAGE (0536-1068-34) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE
Marketing Start Date	2015-03-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 206fff2b-1b9d-4b7f-bcef-b055825d4fe7 Details

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

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

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

Ingredient Name	Strength
Inactive Ingredients
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
Color	red (clear)	Score	no score
Shape	OVAL	Size	10mm
Flavor		Imprint Code	661
Contains

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

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

Labeler - Rugby Laboratories (079246066)

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

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

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

Revised: 6/2022

Document Id: 41f3d525-5f6a-4b3b-bf16-d5fb8efe9625

Set id: 206fff2b-1b9d-4b7f-bcef-b055825d4fe7

Version: 9

Effective Time: 20220630