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Trigofen

TRIGEN Laboratories, Inc.

TRIGOFEN 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 2 mg Decongestant

Trigofen 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 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 the child has

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes mellitus

Ask a doctor before use if the child is taking sedatives or tranquilizers.

When using this product

  • excitability may occur, especially in children
  • may cause marked drowsiness
  • sedatives and tranquilizers may increase drowsiness

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • symptoms persists for more than 1 week, tends to recur, or are 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: 2 dropperfuls (2 mL) every 4 hours not to exceed 12 dropperfuls in 24 hours or as directed by a doctor.
Children under 6 years of age: Consult a physician

Other Information

Store at 59°-86°F (15°-30°C) [see USP Controlled Room Temperature]

Inactive Ingredients

Citric Acid, Glycerin, Methyl Paraben, Orange flavor, Potassium Citrate, Potassium Sorbate, Propyl Paraben, Propylene Glycol, Purified Water, Sucralose, Vanilla flavor

Question? Comments?

Call 888 9 TRIGEN (888-987-4436)

Manufactured for:
TRIGEN
LABORATORIES

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label

NDC 13811- 0081-30

TRIGOFEN
DROPS

Antihistamine • Decongestant
Sugar Free • Alcohol Free • Dye Free

Each dropperful (1 mL) for
oral administration contains:

Chlorpheniramine Maleate 1 mg
Phenylephrine HCl 2 mg

Orange-Vanilla Flavor

1 fl. Oz. (30 mL)

Trigofen

Trigofen

CHLORPHENIRAMINE MALEATE and PHENYLEPHRINE HYDROCHLORIDE SOLUTION/ DROPS

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13811-081
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Chlorpheniramine Maleate CHLORPHENIRAMINE 1 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 2 mg

Inactive Ingredients

Ingredient Name Strength
CITRIC ACID MONOHYDRATE
GLYCERIN
METHYLPARABEN
POTASSIUM CITRATE
POTASSIUM SORBATE
PROPYLPARABEN
propylene glycol
water
Sucralose

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13811-081-30 30 in 1 BOTTLE, DROPPER

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2010-01-01


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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