TRI-DEX PE description, usages, side effects, indications, overdosage, supplying and lots more!

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TRI-DEX PE

TRIGEN Laboratories, Inc.

TRI-DEX PE LIQUID


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active Ingredient (in each 5 mL teaspoonful) Purpose
Chlorpheniramine Maleate 2 mg Antihistamine
Dextromethorphan HBr 15 mg Antitissive
Phenylephrine HCl 10 mg Decongestant

TRI-DEX PE Uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes
  • cough due to minor throat and bronchial irritation
  • nasal congestion
  • reduces swelling of nasal passages
  • nonnarcotic cough suppressant for the relief of cough

Warnings

Do not exceed recommended dosage.

  • a persistent cough may be a sign of a serious condition. If cough persist for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache, consult a doctor

Do not take this product

  • if you are 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
  • for persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor

Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • a persistent or chronic cough that occurs with too much phlegm (mucus)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes mellitus

Ask a doctor before use if you are taking sedatives or tranquilizers.

When using this product

  • excitability may occur, especially in children
  • may cause drowsiness
  • sedatives and tranquilizers may increase drowsiness effect
  • avoid alcoholic beverages
  • use caution when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • if symptoms do not improve within 7 days or are accompanied by fever
  • new symptoms occur

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

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.

Adults and children 12 years of age and over: 1 teaspoonful (5 mL) every 4 hours, not to exceed 6 teaspoonfuls in 24 hours, or as directed by a doctor
Children 6 to under 12 years of age: 1/2 teaspoonful (2.5 mL) every 4 hours, not to exceed 3 teaspoonfuls in 24 hours, or as directed by a doctor
Children 2 to under 6 years of age consult a doctor

TRI-DEX PE Other information

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

Inactive ingredients

Citric Acid, Methyl Paraben, Potassium Citrate, Potassium Sorbate, Propyl Paraben, Propylene Glycol, Purified Water, Sorbitol Solution 70%, Strawberry flavor, Sucralose

Questions? Comments?

Call 888 9 TRIGEN (888-987-4436)

Manufactured for:
TRIGEN
LABORATORIES
Sayresville, NJ 08872

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

NDC 13811-088-16

TRI-DEX PE
LIQUID

Antihistamine ■ Antitussive
Decongestant

Sugar Free ■ Alcohol Free
Dye Free

Each teaspoonful (5 mL)
for oral administration contains:
Chlorpheniramine Maleate 2 mg
Dextromethorphan HBr 15 mg
Phenylephrine HCl 10 mg

STRAWBERRY FLAVOR

This bottle is not to be dispensed
to consumer.

Tamper evident by foil seal under cap.

Do not use if foil seal is
broken or missing.

Dispense in a tight container
with a child-resistant cap.

Manufactured for:
TRIGEN
LABORATORIES
Sayresville, NJ 08872

16 fl oz (473 mL)

TRI-DEX PE

TRI-DEX PE

Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13811-088
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Chlorpheniramine Maleate CHLORPHENIRAMINE 2 mg
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 15 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 10 mg

Inactive Ingredients

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

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13811-088-16 473 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2011-07-01


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Be sure to consult your doctor before taking any medication!
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