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Dextromethorphan HBr and Guaifenesin

Dosage form: solution
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 10mg in 5mL, GUAIFENESIN 100mg in 5mL
Labeler: Hi-Tech Pharmacal Co., Inc.
NDC Code: 50383-062

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.

Drug Facts

Active ingredient

Each 5 mL (1 teaspoonful) contains:

Dextromethorphan HBr ................................10 mg

Guaifenesin ................................................100 mg

Inactive ingredients

Acesulfame potassium, artificial cherry & vanilla flavor, aspartame, hypromellose, menthol, methylparaben, potassium sorbate, purified water. Citric acid may be used to adjust pH.

Purpose

Cough Suppressant

Expectorant

Uses
  • temporarily relieves cough
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus

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 two 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 occur with too much phlegm (mucus)
  • a chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if
  • a cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts

    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.

Professional note: Guaifenesin has been shown to produce a color interference with certain clinical laboratory determinations of 5- hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).

Directions
  • take every 4 hours
  • do not exceed 6 doses in 24 hours
AgeDose
Adults & children 12 years & over10 mL (2 teaspoonfuls)
Children 6 years to under 12 years5 mL (1 teaspoonful)
Children 2 years to under 6 years2.5 mL (1/2 teaspoonful)
Children under 2 yearsAsk a doctor

How Supplied: Dextromethorphan HBr and Guaifenesin Oral Solution is a clear viscous liquid with a slight cherry odor supplied in the following oral dosage forms: 5 mL unit dose, 10 mL unit dose in trays of 10 and 4 fl. oz. (118 mL) bottle

Phenylketonurics: contains phenylalanine 8.4 mg per teaspoonful (5 mL)

Storage: Keep tightly closed. Store at controlled room temperature 20-25° C (68-77°F). [See USP] Protect from light.

QUESTIONS OR COMMENTS?

Call 1-800-262-9010.


Hi-Tech Pharmacal Co., Inc.

Amityville, NY 11701


Rev.062:00 10/10

MG #29851

Package/Label Principal Display Panel

Delivers 10 mL

NDC 50383-062-10

DEXTROMETHORPHAN HBr & GUAIFENESIN ORAL SOLUTION

20 mg/200 mg per 10 mL

Sugar Free/Alcohol Free

COUGH SUPPRESSANT/EXPECTORANT

SEE INSERT

FOR INSTITUTIONAL USE ONLY

Hi-Tech Pharmacal Co., Inc.

Amityville, NY 11701

Rev. 062:00 10/10

DEXTROMETHORPHAN HBR AND GUAIFENESIN 
dextromethorphan hbr and guaifenesin solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50383-062
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
ASPARTAME 
HYPROMELLOSE 2910 (4000 MPA.S) 
MENTHOL 
METHYLPARABEN 
POTASSIUM SORBATE 
WATER 
ANHYDROUS CITRIC ACID 
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRY (artificial cherry flavor) , VANILLA (artificial vanilla flavor) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:50383-062-064 TRAY in 1 CASE
1NDC:50383-062-0510 CUP, UNIT-DOSE in 1 TRAY
15 mL in 1 CUP, UNIT-DOSE
2NDC:50383-062-0710 TRAY in 1 CASE
210 CUP, UNIT-DOSE in 1 TRAY
25 mL in 1 CUP, UNIT-DOSE
3NDC:50383-062-114 TRAY in 1 CASE
3NDC:50383-062-1010 CUP, UNIT-DOSE in 1 TRAY
310 mL in 1 CUP, UNIT-DOSE
4NDC:50383-062-1210 TRAY in 1 CASE
410 CUP, UNIT-DOSE in 1 TRAY
410 mL in 1 CUP, UNIT-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/07/2012
Labeler - Hi-Tech Pharmacal Co., Inc. (101196749)
Establishment
NameAddressID/FEIOperations
Hi-Tech Pharmacal Co., Inc.101196749MANUFACTURE(50383-062)

Revised: 03/2013
 
Hi-Tech Pharmacal Co., Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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