FDA Label for Dextromethorphan Hbr And Guaifenesin Oral Solution

View Indications, Usage & Precautions

DEXTROMETHORPHAN HBR AND GUAIFENESIN ORAL SOLUTION
OTC - ACTIVE INGREDIENT
INACTIVE INGREDIENTS
USES
WARNINGS
ASK A DOCTOR BEFORE USE IF YOU HAVE
OTC - STOP USE
OTC - PREGNANCY OR BREAST FEEDING
OTC - KEEP OUT OF REACH OF CHILDREN
DOSAGE & ADMINISTRATION
HOW SUPPLIED
STORAGE AND HANDLING
OTC - QUESTIONS
PRINCIPAL DISPLAY PANEL - 5 ML UNIT DOSE CUP LABEL
PRINCIPAL DISPLAY PANEL - 10 ML UNIT DOSE CUP LABEL

Dextromethorphan Hbr And Guaifenesin Oral Solution Product Label

The following document was submitted to the FDA by the labeler of this product Kesin Pharma Corporation. 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.

Dextromethorphan Hbr And Guaifenesin Oral Solution

DM Guaifenesin
Non-Narcotic, Sugar, Dye and Alcohol Free
Expectorant/Cough Suppressant

Otc - Active Ingredient


Active Ingredients – 5mL (1 teaspoonful)	Purposes
Guaifenesin 100 mg	Expectorant
Dextromethorphan 5 mg	Cough Suppressant

Inactive Ingredients

Inactive Ingredients: citric acid, grape flavor, methylparaben, monoammonium glycrrhizate, potassium
citrate, propylene glycol, propylparaban, purified
water, sorbitol, sucralose

Uses

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold

helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

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

Ask a doctor before use if you have

Cough that occurs with too much phlegm (mucus)
Cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema.

Otc - Stop Use

cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
you are hypersensitive to any of the ingredients.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions
▪ Do not take more than 6 doses in any 24-hour period


Age	Dose
adults and children 12 years and over	10mL (2 teaspoonful) every 4 hours
children 6 to under 12 years of age	5mL (1 teaspoonful) every 4 hours
children 2 to under 6 years of age	2.5mL (1/2 teaspoonful) every 4 hours
children under 2 years	consult a doctor

How Supplied

Dextromethorphan hydrobromide and Guaifenesin is a clear, grape flavor solution supplied in the following oral dosage forms:
5 mL unit dose cup:
NDC 81033-103-05
Case containing 100 units dose cups of 5 mL:
NDC 81033-103-50
10 mL unit dose cups:
NDC 81033-103-10
Case containing 100 unit dose cups of 10 mL:
NDC 81033-103-51

Storage And Handling

Store at controlled temperature 15°C to 30°C (59°F to 86°F) [See USP]. Protect from light.

Otc - Questions

QUESTIONS OR COMMENTS
Call 1-833-537-4679

Principal Display Panel - 5 Ml Unit Dose Cup Label

NDC 81033-103-05

Dextromethorphan HBr and Guaifenesin Oral Solution

Delivers 10mg/100mg per 5mL

FOR INSTITUTIONAL USE ONLY

Store at 59°F to 86°F (15°C to 30°C)

Principal Display Panel - 10 Ml Unit Dose Cup Label

NDC 81033-103-10