Otc - Active Ingredient
Active ingredients
(in each 5 mL teaspoonful)
Codeine Phosphate 10 mg ................................................... Antitussive
Dexbrompheniramine Maleate 1 mg ................................. Antihistamine
The following Structured Product Label (SPL) was submitted to the FDA by Poly Pharmaceuticals, Inc. for the product Duratuss Ac (NDC 50991-540). 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 - purpose, indications & usage, warnings, otc - ask doctor/pharmacist, otc - ask doctor, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredients
(in each 5 mL teaspoonful)
Codeine Phosphate 10 mg ................................................... Antitussive
Dexbrompheniramine Maleate 1 mg ................................. Antihistamine
Antihistamine
Antitussive
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.
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.
Ask a doctor before use if you have
When using this product
Stop use and ask a doctor if
If pregnant or breastfeeding 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
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.
Directions
Adults 12 and over: 10 mL every 4-6 hours
Not to exceed 60 mL in 24 hours or as directed by a doctor
Children 6-12: 5 mL every 4 hours,
Not to exceed 30 mL in 24 hrs or as directed by a doctor
Children under 6: 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
Inactive ingredients Cherry flavor, citric acid, glycerin, propylene glycol, purified water,sodium benzoate, sodium citrate, sorbitol solution, sucralose.
* Please review the disclaimer below.