FDA Label for Delsym
View Indications, Usage & Precautions
Delsym Product Label
The following document was submitted to the FDA by the labeler of this product Rebel Distributors Corp. 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
Dextromethorphan Polistirex
Purpose
Use(s)
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
Uses
Use(s)
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
Warnings
Do not use
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
• chronic cough that lasts as occurs with smoking, asthma or emphysema
• cough that occurs with too much phlegm (mucus)
Ask a doctor or pharmacist before use if you are
When using this product
Stop use and ask a doctor if
Stop use and ask a doctor if 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.
If pregnant or breast-feeding
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.
Directions
Directions
• 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 a doctor
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
Other information
• each 5 mL contains: sodium 7 mg
• store at 20°-25°C (68°-77°F)
• dosing cup provided
Drug Facts
Distributed by: Reckitt Benckiser Inc., Parsippany, NJ 07054-0224 ©RBI 2009
Inactive Ingredients
Inactive ingredients
citric acid anhydrous, D&C Red #33, edetate disodium, ethylcellulose, FD&C Blue #1, flavor, high fructose corn syrup, methylparaben, polyethylene glycol 3350, polysorbate 80, propylene glycol, propylparaben,
purified water, sucrose, tragacanth, vegetable oil, xanthan gum
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