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CARDEC

Macoven Pharmaceuticals

CARDEC™ Drops


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active Ingredients (in each 1 mL dropperful) Purpose
Chlorpheniramine Maleate 1 mg Antihistamine
Phenylephrine HCl 3.5 mg Nasal Decongestant

CARDEC 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 is 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. 1-800-222-1222

Directions

Do not exceed recommended dosage.

Children 6 to under 12 years of age: 1 dropperful (1 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

CARDEC 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, Grape flavor, Methyl Paraben, Potassium Citrate, Potassium Sorbate, Propyl Paraben, Propylene Glycol, Purified Water, Sucralose

Question? Comments?

Call 1-877-622-6836

PRINCIPAL DISPLAY PANEL - 30 mL Carton

NDC 44183-604-30

CARDEC™
Drops

Antihistamine • Nasal Decongestant
Sugar Free • Alcohol Free • Gluten Free

Grape Flavor

Active Ingredients:
Each dropperful (1mL) for oral
administration contains:
Chlorpheniramine Maleate 1 mg
Phenylephrine HCl 3.5 mg

WARNING: KEEP THIS AND ALL MEDICATIONS
OUT OF THE REACH OF CHILDREN.

Net Contents: 1 fl. oz. (30 mL)

Manufactured for:
MACOVEN
PHARMACEUTICALS
Magnolia, TX 77354

CARDEC

CARDEC

PHENYLEPHRINE HYDROCHLORIDE and CHLORPHENIRAMINE MALEATE LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:44183-604
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Phenylephrine Hydrochloride PHENYLEPHRINE 3.5 mg
Chlorpheniramine Maleate CHLORPHENIRAMINE 1 mg

Inactive Ingredients

Ingredient Name Strength
CITRIC ACID MONOHYDRATE
FD&C BLUE NO. 1
FD&C RED NO. 40
GLYCERIN
GRAPE
METHYLPARABEN
POTASSIUM CITRATE
POTASSIUM SORBATE
PROPYLPARABEN
propylene glycol
water
Sucralose

Product Characteristics

Color
PURPLE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 30 in 1 BOTTLE
2 NDC:44183-604-30 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2011-06-09


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Be sure to consult your doctor before taking any medication!
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