Dextromethorphan HBr and Guaifenesin description, usages, side effects, indications, overdosage, supplying and lots more!

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Dextromethorphan HBr and Guaifenesin

Hi-Tech Pharmacal Co., Inc.

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




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
Age Dose
Adults & children 12 years & over 10 mL (2 teaspoonfuls)
Children 6 years to under 12 years 5 mL (1 teaspoonful)
Children 2 years to under 6 years 2.5 mL (1/2 teaspoonful)
Children under 2 years Ask 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

Dextromethorphan HBr and Guaifenesin

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 Type Human otc drug label Item Code (Source) NDC:50383-062
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 10 mg
Guaifenesin GUAIFENESIN 100 mg

Inactive Ingredients

Ingredient Name Strength
ACESULFAME POTASSIUM
ASPARTAME
HYPROMELLOSE 2910 (4000 MPA.S)
MENTHOL
METHYLPARABEN
POTASSIUM SORBATE
water
ANHYDROUS CITRIC ACID

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 5 in 1 CUP, UNIT-DOSE
2 5 in 1 CUP, UNIT-DOSE
3 10 in 1 CUP, UNIT-DOSE
4 10 in 1 CUP, UNIT-DOSE
5 10 in 1 TRAY
6 NDC:50383-062-12 10 in 1 CASE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2012-03-07


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