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  5. Label Information: Rycontuss Cherry Flavor

FDA Label for Rycontuss Cherry Flavor

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. WARNINGS
    4. OTC - ASK DOCTOR
    5. OTC - ASK DOCTOR/PHARMACIST
    6. OTC - WHEN USING
    7. OTC - STOP USE
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. INDICATIONS & USAGE
    10. DOSAGE & ADMINISTRATION
    11. STORAGE AND HANDLING
    12. INACTIVE INGREDIENT
    13. OTC - QUESTIONS
    14. DESCRIPTION
    15. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rycontuss Cherry Flavor Product Label

The following document was submitted to the FDA by the labeler of this product Okendpharma, Inc.. 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.

Otc - Active Ingredient



Active ingredients                                                                                       Purpose
Chlorpheniramine Maleate 2mg............................................................Antihistamine
Dextromethorphan Hydrobromide 10mg.........................................Cough Supressant
Phenylephrine Hydrochloride 5mg...............................................Nasal Decongestant


Otc - Purpose



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



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.


Otc - Ask Doctor



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.


Otc - Ask Doctor/Pharmacist



Ask a doctor or pharmacist if you are taking sedatives or tranquilizers.


Otc - When Using



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.


Otc - Stop Use



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.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.


Indications & Usage



In case of overdose, get medical help or contact a poison control center right away.


Dosage & Administration




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


Storage And Handling



Other information  - Store at controlled room temperature between 15-30 C (58-86F)  - Avoid excessive heat or humidity.


Inactive Ingredient



Inactive Ingredients
Citric acid, DandC red #33, FDandC red #40, flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate and sucrose.


Otc - Questions



Questions or comments  Phone: 1-787-548-0016, Labor hours 8:00 am to 5:00 pm


Description



Manufactured for:  Okendpharma Inc,  4287 Constancia Ave. Villa Del Carmen Ponce, PR 00716  United States  Product of Puerto Rico


Package Label.Principal Display Panel



NDC  RYCONTUSS Liquid  CHERRY FLAVOR  ANTITUSSIVE NASAL  DECONGESTANT AND ANTIHISTAMINE  16 fl oz (1 print) (473 ml)  Lot #  Exp.Date

Rycontuss - Rycontuss

Rycontuss - Rycontuss


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