Major 44-178

Major 44-178
SPL v20
SPL
SPL Set ID 2b0171a1-3f08-4360-aba3-b13344a52623
Route
ORAL
Published
Effective Date 2023-02-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pseudoephedrine (60 mg) Triprolidine (2.5 mg)
Inactive Ingredients
Silicon Dioxide Starch, Corn Hypromellose, Unspecified Anhydrous Lactose Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Stearic Acid Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 44;178 Shape: round Color: white Size: 7 mm Score: 2
Marketing Status
OTC MONOGRAPH FINAL Active Since 1993-01-09

Description

Pseudoephedrine HCl 60 mg Triprolidine HCl 2.5 mg

Purpose

Nasal decongestant Antihistamine

How Supplied

Product: 50090-0622 NDC: 50090-0622-2 24 TABLET, FILM COATED in a BLISTER PACK / 1 in a CARTON


Medication Information

Purpose

Nasal decongestant

Antihistamine

How Supplied

Product: 50090-0622

NDC: 50090-0622-2 24 TABLET, FILM COATED in a BLISTER PACK / 1 in a CARTON

Description

Pseudoephedrine HCl 60 mg Triprolidine HCl 2.5 mg

Uses
  • temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:
    • runny nose
    • itchy, watery eyes
    • nasal congestion
    • sneezing
    • itching of the nose or throat
  • temporarily relieves these symptoms due to the common cold:
    • runny nose
    • sneezing
    • nasal congestion
Warnings



Directions
  • adults and children 12 years and over: take 1 tablet every 4 to 6 hours. Do not take more than 4 tablets in 24 hours.
  • children under 12 years: do not use
Do Not Use

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.

Other Information
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number
Inactive Ingredients

colloidal silicon dioxide, corn starch, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, stearic acid, titanium dioxide

Questions Or Comments?

(800) 616-2471

When Using This Product
  • do not exceed recommended dosage
  • excitability may occur, especially in children
  • use caution when driving a motor vehicle or operating machinery
  • drowsiness may occur
  • avoid alcoholic beverages
  • alcohol, sedatives and tranquilizers may increase drowsiness
Stop Use and Ask A Doctor If
  • nervousness, dizziness or sleeplessness occur
  • symptoms do not improve within 7 days or occur with a fever
If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Active Ingredients (in Each Tablet)

Pseudoephedrine HCl 60 mg

Triprolidine HCl 2.5 mg

Ask A Doctor Before Use If You Have
  • high blood pressure
  • heart disease
  • thyroid disease
  • diabetes
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urination due to enlargement of the prostate gland
Pseudoephedrine Hcl and Tripolidine
Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers.


Structured Label Content

Uses
  • temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:
    • runny nose
    • itchy, watery eyes
    • nasal congestion
    • sneezing
    • itching of the nose or throat
  • temporarily relieves these symptoms due to the common cold:
    • runny nose
    • sneezing
    • nasal congestion
Purpose

Nasal decongestant

Antihistamine

Warnings



Directions
  • adults and children 12 years and over: take 1 tablet every 4 to 6 hours. Do not take more than 4 tablets in 24 hours.
  • children under 12 years: do not use
Do Not Use (Do not use)

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.

How Supplied (HOW SUPPLIED)

Product: 50090-0622

NDC: 50090-0622-2 24 TABLET, FILM COATED in a BLISTER PACK / 1 in a CARTON

Other Information (Other information)
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number
Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, corn starch, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, stearic acid, titanium dioxide

Questions Or Comments? (Questions or comments?)

(800) 616-2471

When Using This Product (When using this product)
  • do not exceed recommended dosage
  • excitability may occur, especially in children
  • use caution when driving a motor vehicle or operating machinery
  • drowsiness may occur
  • avoid alcoholic beverages
  • alcohol, sedatives and tranquilizers may increase drowsiness
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • nervousness, dizziness or sleeplessness occur
  • symptoms do not improve within 7 days or occur with a fever
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Active Ingredients (in Each Tablet) (Active ingredients (in each tablet))

Pseudoephedrine HCl 60 mg

Triprolidine HCl 2.5 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • high blood pressure
  • heart disease
  • thyroid disease
  • diabetes
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urination due to enlargement of the prostate gland
Pseudoephedrine Hcl and Tripolidine (Pseudoephedrine HCl and Tripolidine)
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers.


Advanced Ingredient Data


Raw Label Data

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