Otc - Active Ingredient
Active ingredients
(in each 5 mL teaspoonful)
Dextromethorphan HBr............... 7.5 mg
Phenylephrine HCl....................... 5 mg
Pyrilamine Maleate................. 12.5 mg
The following Structured Product Label (SPL) was submitted to the FDA by Poly Pharmaceuticals, Inc. for the product Polytussin Dm (NDC 50991-132). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - ask doctor/pharmacist, indications & usage, warnings, otc - ask doctor, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredients
(in each 5 mL teaspoonful)
Dextromethorphan HBr............... 7.5 mg
Phenylephrine HCl....................... 5 mg
Pyrilamine Maleate................. 12.5 mg
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.
Uses
temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
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
When using this product
Stop use and ask a doctor if
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
Do not exceed recommended dosage.
Adults and children 12 years of age and over: 2 teaspoonfuls (10 mL) every 4 to 6 hours, not to exceed 12 teaspoonfuls in 24 hours
Children 6 to under 12 years of age:1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 6 teaspoonfuls in 24 hours
Children under 6 years of age: Consult a doctor
Other information
Store at room temperature 15°C-30°C (59°F-86°F)
Questions? Comments? Serious side effects associated with use of this product may be reported to this number. Call 1-800-882-1041
Mon. - Fri. (8 a.m. to 5 p.m. CST).
Inactive ingredients
Citric Acid, Flavor, Methylparaben, Potassium Citrate, Propylene Glycol, Propylparaben, Purified water, Sucralose, Sorbitol
Antihistamine
Cough Suppressant
Nasal Decongestant
* Please review the disclaimer below.