TRIP-PSE

Dosage form: liquid
Ingredients: TRIPROLIDINE HYDROCHLORIDE 0.938mg in 1mL, PSEUDOEPHEDRINE HYDROCHLORIDE 10mg in 1mL
Labeler: Macoven Pharmaceuticals
NDC Code: 44183-201

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.

TRIP-PSE

Drug Facts

Active ingredients
(in each mL)
Purpose
Triprolidine HCl 0.938 mgAntihistamine
Pseudoephedrine HCl 10 mgNasal decongestant

Uses
  • temporarily relieves
    • runny nose
  • relieves;
    • sneezing
    • itching of nose and throat
    • itchy, watery eyes due to hay fever or other upper respiratory allergies
    • nasal congestion due to the common cold

Warnings

  • May cause excitability, especially in children

Do Not Use
  • if you or your child are taking sedatives or tranquilizers, without first consulting your doctor
  • if you or your child 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if your child has
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • heart disease
  • high blood pressure
  • diabetes
  • thyroid disease
  • difficulty in urination due to enlargement of the prostate gland

When using this product
  • do not use more than directed
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if:

  • nervousness, dizziness or sleeplessness occurs
  • symptoms do not improve within 7 days or are accompanied by a fever

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

Keep out of reach of children.

Overdose warning

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions
  • take every 6 hours
  • do not take more than 4 doses in 24 hours or as directed by a doctor
  • do not give more than directed or exceed the recommended daily dosage
Adults and children 12 years of age and over2.67 mL
Children 6 to under 12 years of age1.33 mL
Children under 6 years of ageAsk a Doctor

Other Information
  • store at controlled room temperature 20°-25°C (68°-77°F)

Tamper Evident: Do not use if seal is broken or missing.

Inactive ingredients

Artificial cotton candy flavor, bitter mask, citric acid, FD&C red #40, glycerin, magnesium aluminometasilicate, methylparaben, purified water, sodium citrate dihydrate, sucralose, galloquinate, xanthan gum, xylitol

Questions?

Call 1-877-622-6836

PRINCIPAL DISPLAY PANEL - 30 mL Carton

NDC# 44183-201-30

TRIP-PSE

Triprolidine HCl (Antihistamine)
Pseudoephedrine HCl (Nasal Decongestant)
1 oz (30mL)

Caution: Law
prohibits dispensing
without a prescription

MACOVEN
Pharmaceuticals

TRIP-PSE 
triprolidine hydrochloride and pseudoephedrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44183-201
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRIPROLIDINE HYDROCHLORIDE (TRIPROLIDINE) TRIPROLIDINE HYDROCHLORIDE0.938 mg  in 1 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
FD&C RED NO. 40 
GLYCERIN 
MAGNESIUM ALUMINOMETASILICATE TYPE I-A 
METHYLPARABEN 
WATER 
SODIUM CITRATE 
SUCRALOSE 
TANNIC ACID 
XANTHAN GUM 
XYLITOL 
Product Characteristics
ColorREDScore    
ShapeSize
FlavorCOTTON CANDYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:44183-201-301 BOTTLE (BOTTLE) in 1 BOX
130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34102/08/2010
Labeler - Macoven Pharmaceuticals (832591965)

Revised: 04/2011
 
Macoven Pharmaceuticals

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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