Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 7af63769-fa56-4f1f-a2ad-5b4c108c8e4f
Route
ORAL
Published
Effective Date 2019-12-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenylephrine (10 mg) Chlorpheniramine (4 mg)
Inactive Ingredients
Silicon Dioxide Magnesium Stearate Stearic Acid Croscarmellose Sodium Microcrystalline Cellulose

Identifiers & Packaging

Pill Appearance
Shape: round Color: white Size: 7 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-12-23

Description

Phenylephrine HCl 10 mg Chlorpheniramine maleate 4mg

Purpose

Nasal Decongestant Antihistamine


Medication Information

Purpose

Nasal Decongestant

Antihistamine

Description

Phenylephrine HCl 10 mg Chlorpheniramine maleate 4mg

Uses

temporarily relieves nasal congestion due to the common cold, and these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes
  • nasal congestion
  • sinus congestion and pressure
Directions

Adults and children 12 years of age and older: 1 tablet every 4 to 6 hours. Do not take more than 6 doses in 24 hours

Children under 12 years of age: Consult a doctor

Do Not Use

if you are now taking a prescription monoamine oxadise 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
  • store at room temperature
  • do not use if blister unit is torn or open
Inactive Ingredients

croscarmellose sodium, lactose anhydrous, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid

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

ask a health professional before use.

Keep Out of Reach of Children

In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical even if you do not notice any signs or symptoms.

Active Ingredients (in Each Tablet)

Phenylephrine HCl 10 mg

Chlorpheniramine maleate 4mg

Ask A Doctor Before Use If You Have
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • diabetes
  • heart disease
  • high blood pressure
  • thyroid disease
Package/label Principal Display Panel
Cold and Allergy
Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers


Structured Label Content

Uses

temporarily relieves nasal congestion due to the common cold, and these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes
  • nasal congestion
  • sinus congestion and pressure
Purpose

Nasal Decongestant

Antihistamine

Directions

Adults and children 12 years of age and older: 1 tablet every 4 to 6 hours. Do not take more than 6 doses in 24 hours

Children under 12 years of age: Consult a doctor

Do Not Use

if you are now taking a prescription monoamine oxadise 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
  • store at room temperature
  • do not use if blister unit is torn or open
Inactive Ingredients

croscarmellose sodium, lactose anhydrous, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid

When Using This Product (When using this product)
  • do not use more than directed
  • may cause excitability, especially in children
  • may cause drowsiness; alcohol, sedatives or tranquilizers may increase drowsiness 
  • avoid alcoholic beverages and use caution  when driving a motor vehicle or operating machinery
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 are accompanied by 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 accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical even if you do not notice any signs or symptoms.

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

Phenylephrine HCl 10 mg

Chlorpheniramine maleate 4mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • diabetes
  • heart disease
  • high blood pressure
  • thyroid disease
Package/label Principal Display Panel (Package/Label Principal Display Panel)
Cold and Allergy
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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