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  5. Label Information: Gencontuss

FDA Label for Gencontuss

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. ACTIVE INGREDIENTS (IN EACH 5ML TEASPOONFUL)
    3. PURPOSE
    4. OTC - KEEP OUT OF REACH OF CHILDREN
    5. USES
    6. WARNINGS
    7. DOSAGE & ADMINISTRATION
    8. INACTIVE INGREDIENT
    9. OTHER INFORMATION
    10. OTC - QUESTIONS
    11. OTHER
    12. PACKAGING

Gencontuss Product Label

The following document was submitted to the FDA by the labeler of this product Kramer Novis. 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.

Drug Facts




Active Ingredients (In Each 5Ml Teaspoonful)



Chlorpheniramine Maleate, 2 mg

Dextromethorphan HBr, 10 mg

Phenylephrine HCL, 5 mg


Purpose



Antihistamine

Cough Suppressant

Nasal Decongestant


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.


Uses



• For 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 or 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, psychiatric 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  • Glaucoma  • Trouble urinating due to the enlarged prostate gland  • 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 before use 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 last more than 7 days, comes back or is accompanied by fever, rash, or persistent headaches. These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.


Dosage & Administration



Directions. Do not exceed 6 doses in any 24 hour period


Inactive Ingredient



Inactive ingredients: cherry flavor, citric acid, FD&C red#40, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose and sucrose.


Other Information



• Tamper evident feature: Do not use if inner seal is torn, broken or missing.

• Store at controlled room temperature 15-30⁰C(59-86⁰F).

• Avoid excessive heat or humidity.


Otc - Questions



Questions or comments? Manufactured in USA for Kramer Novis, San Juan, P.R. 00917 Tel:(787) 767-2072/ www.kramernovis.com


Other



THIS IS A BULK CONTAINER NOT INTENDED FOR DISPENSING

Pharmacist: Preserve and dispense in a tight light resistant container with a child resistant cap as defined in the USP.

*RYCONTUSS® is a registered trademark of Okendpharma Inc.

This product is not manufactured, distributed or marketed by Okendpharma Inc.


* Please review the disclaimer below.