OTC Medication Information: Dextromethorphan HBr

DEXTROMETHORPHAN HBR- dextromethorphan hydrobromide 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.

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 UNDERCAP IS BROKEN OR MISSING

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

Rugby 44-732
(click image for full-size original)

Rugby 44-732

DEXTROMETHORPHAN HBR dextromethorphan hbr capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-1323
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 15 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 1 ALUMINUM LAKE
FD&C RED NO. 40
GELATIN, UNSPECIFIED
GLYCERIN
ISOPROPYL ALCOHOL
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
PROPYL GALLATE
PROPYLENE GLYCOL
WATER
SORBITAN
SORBITOL
MEDIUM-CHAIN TRIGLYCERIDES
Product Characteristics
Color red (clear) Score no score
Shape OVAL Size 14mm
Flavor Imprint Code 732
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0536-1323-34 1 BOTTLE, PLASTIC in 1 PACKAGE contains a BOTTLE, PLASTIC
1 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC This package is contained within the PACKAGE (0536-1323-34)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 10/30/2020
Labeler — Rugby Laboratories (079246066)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 038154464 pack (0536-1323)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 967626305 pack (0536-1323)

Revised: 10/2021 Rugby Laboratories

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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