OTC - ACTIVE INGREDIENT SECTION
Active ingredient (per 5ml teaspoonful)
Dextromethorphan HBr, USP, 10 mg
Guaifenesin, USP 100 mg
OTC - PURPOSE SECTION
Purpose
Cough suppressant
Expectorant
INDICATIONS & USAGE SECTION
Uses
- •temporarily relieves cough due to minor throat and bronchial irritation
- •helps loosen phlegm (mucus)
- •helps thin bronchial secretions to make coughs more productive
WARNINGS SECTION
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.
Do not use if you have ever had an allergic reaction to any of the ingredients in this product.
Ask a doctor before use if you have
Stop use and ask a doctor if cough lasts more than 7 days, comes back or is accompanied by fever, rash, or headache that lasts. These could be signs of a serious condition.
- •a cough with too much phlegm (mucus)
- •a cough that lasts or is chronic such as occurs with smoking asthma, chronic bronchitis or emphysema.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away
DOSAGE & ADMINISTRATION SECTION
Directions
| Adults and children 12 years and over | 2 teaspoonfuls (10 mL) |
| Children under 12 years | do not use |
- •take every 4 hours as needed, or as directed by a doctor
- •do not take more than 6 doses in 24 hours
- •do not exceed recommended dose
INACTIVE INGREDIENT SECTION
Inactive ingredients: Cherry flavor, citric acid, FD&C Red #40, menthol, methylparaben, propylene glycol, propylparaben, water, sodium citrate, sucralose, sucrose.
Other Information
Pharmacist- Preserve and dispense in a tight, light-resistant container with a child resistant cap as defined in the USP
- •Each teaspoonful (5 mL) contains: sodium 2 mg
- •Store at room temperature 15°-30°C (59°-86°F)
- •Protect from freezing
- •Do not refrigerate
- •Protect from light
SPL UNCLASSIFIED SECTION
Distributed By:
MAJOR® PHARMACEUTICAL
Livonia, MI 48152
Refer to package label for Distributor's NDC Number
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Guaifenesin Dextromethorphan Oral Solution
200 mg/20 mg per 10 mL
Delivers 10 mL