Dextromethorphan HBr and Guaifenesin

Hi-Tech Pharmacal Co., Inc.

Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient
• Inactive ingredients
• Purpose
• Dextromethorphan HBr and Guaifenesin Uses
• Warnings
  • Do not use
  • Ask a doctor before use if you have
  • Stop use and ask a doctor if
  • If pregnant or breast-feeding,
  • Keep out of reach of children.
• Directions
• QUESTIONS OR COMMENTS?
• Package/Label Principal Display Panel

FULL PRESCRIBING INFORMATION

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

Dextromethorphan HBr and Guaifenesin 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

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