The following Structured Product Label (SPL) was submitted to the FDA by Okendpharma, Inc. for the product Rycontuss (NDC 76117-001). 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, warnings, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredients Purpose
Chlorpheniramine Maleate 2mg............................................................Antihistamine
Dextromethorphan Hydrobromide 10mg.........................................Cough Supressant
Phenylephrine Hydrochloride 5mg...............................................Nasal Decongestant
Uses - For the temporary relief of runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever - Temporarily relieves cough due to minor throat and bronchial irritation occurring with the common cold - Temporarily restores freer breathing through the nose
Warnings Do not use - To sedate a child or to make a child sleepy. - If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psyquiatric or emotional condition, or for 2 weeks after stopping the MAOI drug. - If you do not know if your prescription drug contains a MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have - Heart disease. - Thyroid disease. - Trouble urinating due to enlarged prostate gland. - Glaucoma. - Cough that occurs with too much phlegm (mucus). - Breathing problems or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis or emphysema.
Ask a doctor or pharmacist if you are taking sedatives or tranquilizers.
When using this product - Do not use more than directed. - May cause marked drowsiness. - Avoid alcoholic beverages. - Alcohol, sedatives and tranquilizers may cause increased drowsiness. - Be careful when driving a motor vehicle or operating machinery. - Excitability may occur, especially with children.
Stop use and ask a doctor if - You get nervous, dizzy, or sleepless. - Cough lasts more than 7 days, come back, or is accompanied by a fever, rash, or persistent headaches. These could be signs of a serious condition. 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.
| Adults and children 12 or older | 2 tsp (10 mL) every 4 hours |
| Chidren age 6 - 12 | 1 tsp (5 mL) every 4 hours |
| Children younger than 6 | Ask a doctor |
Other information - Store at controlled room temperature between 15-30 C (58-86F) - Avoid excessive heat or humidity.
Inactive Ingredients
Citric acid, DandC red #33, FDandC red #40, flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate and sucrose.
Questions or comments Phone: 1-787-548-0016, Labor hours 8:00 am to 5:00 pm
Manufactured for: Okendpharma Inc, 4287 Constancia Ave. Villa Del Carmen Ponce, PR 00716 United States Product of Puerto Rico
NDC RYCONTUSS Liquid CHERRY FLAVOR ANTITUSSIVE NASAL DECONGESTANT AND ANTIHISTAMINE 16 fl oz (1 print) (473 ml) Lot # Exp.Date
Rycontuss (Rycontuss)
* Please review the disclaimer below.
