OTC Medication Information: Virdec Drops
VIRDEC DROPS — phenylephrine hydrochloride and chlorpheniramine maleate liquid
Virtus Pharmaceuticals, LLC
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Facts
Active Ingredient (in each 1mL dropperful)
Chlorpheniramine Maleate 1 mg
Phenylephrine HCl 3.5 mg
Purpose
Antihistamine
Nasal Decongestant
Uses
Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other respiratory allergies:
- runny nose
- sneezing
- itching of the nose or throat
- itchy, watery eyes
- nasal congestion
- reduces swelling of nasal passages
Warnings
Do not exceed recommended dosage.
Do not use this product in a child who is
- 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 a child has
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- heart disease
- high blood pressure
- thyroid disease
- diabetes mellitus
Ask a doctor or pharmacist before use if a child taking sedatives or tranquilizers.
When using this product
- excitability may occur, especially in children
- may cause drowsiness
- sedatives and tranquilizers may increase drowsiness effect
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- symptoms persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. These could be signs of a serious condition.
- new symptoms occur
Keep out of reach of children.
In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.
Directions
Do not exceed recommended dosage.
| Children 6 to under 12 years of age: | 1 dropperful (2 mL) every 4 to 6 hours, not to exceed 6 dropperfuls in 24 hours or as directed by a doctor |
| Children under 6 years of age: | Consult a doctor |
Other information
Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].
Inactive Ingredients
Citric Acid, FD&C Blue # 1, FD&C Red # 40, Glycerin, Raspberry flavor, Methyl Paraben, Potassium Citrate, Potassium Sorbate, Propyl Paraben, Propylene Glycol, Purified Water, Sucralose
Question? Comments?
Call 813-283-1344
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL – 30mL Carton
NDC 76439-319-30
Virdec Drops
Antihistamine • Decongestant Sugar Free • Alcohol Free • Gluten Free
Active Ingredient:
Each dropperful (1mL) contains:
Chlorpheniramine Maleate………1 mg
Phenylephrine HCl……………….3.5 mg
WARNING: KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN
Raspberry Flavor
Virtus Pharmceuticals
NET CONTENTS 1 FL OZ (30 mL)
Dropper Enclosed
Tamper evident by foil seal under cap.
Do not use if foil seal is broken or missing.
Supplied with a child resistant cap.
| VIRDEC DROPS virdec drops liquid | ||||||||||||||||||||||||
| ||||||||||||||||||||||||
| ||||||||||||||||||||||||
| ||||||||||||||||||||||||
| ||||||||||||||||||||||||
| ||||||||||||||||||||||||
| ||||||||||||||||||||||||
| Labeler — Virtus Pharmaceuticals, LLC (969483143) |
| Registrant — Virtus Pharmacueticals, LLC (969483143) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Axcentria Pharmaceuticals | 961871501 | MANUFACTURE | |
Revised: 02/2012 Virtus Pharmaceuticals, LLC
