Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each 5 mL)
Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide, USP
OTC - PURPOSE SECTION
Purpose
Cough suppressant
INDICATIONS & USAGE SECTION
Uses
temporarily relieves
- cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
- the impulse to cough to help you get to sleep
WARNINGS SECTION
Warnings
OTC - DO NOT USE SECTION
Do not useif 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.
Allergy Alert
Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions.
Ask a doctor before use if you have
- chronic cough that lasts as occurs with smoking, asthma, or emphysema
- cough that occurs with too much phlegm (mucus)
Stop use and ask a doctor if
- side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
- cough lasts more than 7 days, cough comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.
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 right away 1-800-222-1222.
DOSAGE & ADMINISTRATION SECTION
Directions
| adults and children 12 years of age and over | 10 mL every 12 hours, not to exceed 20 mL in 24 hours |
| children 6 to under 12 years of age | 5 mL every 12 hours, not to exceed 10 mL in 24 hours |
| children 4 to under 6 years of age | 2.5 mL every 12 hours, not to exceed 5 mL in 24 hours |
| children under 4 years of age | do not use |
- shake bottle well before use
- measure only with dosing cup provided. Do not use dosing cup with other products
- dose as follows or as directed by doctor
- mL = milliliter
STORAGE AND HANDLING SECTION
Other information
- each 5 mL contains: sodium 5 mg
- store at 20-25°C (68-77°F)
- dosing cup provided
INACTIVE INGREDIENT SECTION
Inactive ingredients(Grape flavor)
D&C red no. 30, FD&C blue no. 1, flavor, glycerin, high fructose corn syrup, methylparaben, polysorbate 80, polyvinyl acetate, povidone, propylparaben, purified water, sodium metabisulfite, sodium polystyrene sulfonate, sucrose, tartaric acid, tragacanth gum, triacetin, xanthan gum
INACTIVE INGREDIENT SECTION
Inactive ingredients(Orange flavor)
D&C red no. 30, D&C yellow no. 10, flavor, glycerin, high fructose corn syrup, methylparaben, polysorbate 80, polyvinyl acetate, povidone, propylparaben, purified water, sodium metabisulfite, sodium polystyrene sulfonate, sucrose, tartaric acid, tragacanth gum, triacetin, xanthan gum
OTC - QUESTIONS SECTION
Questions?
call weekdays from 9 AM to 5 PM EST at 1-800-762-4675. You may also report side effects to this number.
For most recent product information, visit www.robitussin.com
SPL UNCLASSIFIED SECTION
Distributed by: Pfizer, Madison, NJ 07940 USA