FDA Label for Dextromethorphan Hbr And Guaifenesin
View Indications, Usage & Precautions
Dextromethorphan Hbr And Guaifenesin Product Label
The following document was submitted to the FDA by the labeler of this product Akorn. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
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
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.062:01 4/13
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. 062:01 4/13
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