FDA Label for Guaifenesin And Dextromethorphan Hydrobromide

View Indications, Usage & Precautions

ACTIVE INGREDIENTS
USES
WARNINGS
DO NOT USE THIS PRODUCT
ASK A DOCTOR BEFORE USE IF YOU HAVE
STOP USE AND ASK A DOCTOR IF
IF PREGNANT OR BREAST-FEEDING,
DIRECTIONS
INACTIVE INGREDIENTS
OTHER INFORMATION
OTC - KEEP OUT OF REACH OF CHILDREN
OVERDOSAGE
OTC - QUESTIONS
PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Guaifenesin And Dextromethorphan Hydrobromide Product Label

The following document was submitted to the FDA by the labeler of this product Oncor Pharmaceuticals. 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 Ingredients

(in each 5 mL teaspoonful) Purpose

Dextromethorphan
Hydrobromide 10 mg..........Cough Suppressant
Guaifenesin 200 mg.......................Expectorant

Uses

temporarily Relieves

- cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants

- the intensity of coughing

- the impulse to cough to help you get to sleep

Warnings

Do not exceed recommended dosage.

Do Not Use This Product

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

- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema

- cough that occurs with too much phlegm (mucus)

Stop Use And Ask A Doctor If

- 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.

Directions

do not exceed recommended dosage.


adults and children 12 years and over:	2 teaspoonfuls (10 mL) every 4 hours, not to exceed 12 teaspoonfuls in 24 hours or as directed by a doctor
children 6 to under 12 years of age:	1 teaspoonful (5 mL) every 4 hours, not to exceed 6 teaspoonfuls in 24 hours or as directed by a doctor
children under 6 years of age:	consult a physician

Inactive Ingredients

cherry flavor, citric acid, FD&C red no. 40, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol solution, sucralose.

Other Information

- store at 59°-86°F (15°-30°C) [see USP Controlled Room Temperature]

- tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Overdosage

In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

Otc - Questions

You may report side effects by calling Oncor Pharmaceuticals (9 a.m. to 5 p.m. EST), at 1-443-876-7600 or FDA at 1-800-FDA-1088.

Principal Display Panel

Oncor Pharmaceuticals

NDC 83720-505-16

Guaifenesin and Dextromethorphan hydrobromide USP

200 mg/10 mg

Expectorant
Cough Suppressant

Non Drowsy - Alcohol Free

For Ages 12 & Up

CHERRY FLAVOR

NET WT. 16 fl. oz. (473 ml)

NDC 83720-505-04