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SPL v8
SPL
SPL Set ID ccedbc38-2479-4c35-9f86-a9f29bcfab3f
Route
ORAL
Published
Effective Date 2022-08-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorcyclizine (25 mg) Pseudoephedrine (60 mg)
Inactive Ingredients
Microcrystalline Cellulose Magnesium Stearate Sodium Starch Glycolate Type A Potato

Identifiers & Packaging

Pill Appearance
Imprint: M625 Shape: oval Color: white Size: 16 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2011-12-20

Description

Drug Facts


Medication Information

Description

Drug Facts

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
  • nasal congestion
  • reduces swelling of nasal passages
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

Section 50568-5

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

Section 51945-4

Add image transcription here...

Section 53414-9

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

Section 55105-1
Active Ingredients

(in each immediate-release tablet)
Purpose
Chlorcyclizine HCl 25 mg Antihistamine
Pseudoephedrine HCl 60 mg Nasal Decongestant
Warnings

Do not exceed recommended dosage.

Directions

Do not exceed recommended dosage.

Adults and children 12 years of age and over: 1 tablet by mouth every 6-8 hours, not to exceed 3 tablets in 24 hours, or as directed by a doctor
Children 6 to under 12 years of age: ½ tablet by mouth every 6-8 hours, not to exceed 1½ tablets in 24 hours, or as directed by a doctor
Children under 6 years of age Consult a doctor
Inactive Ingredients

Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate

Questions Or Comments?

Call 1-888-206-5525 • www.magnaweb.com

Do Not Use This Product
  • If you are taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for two weeks after stopping the MAOI drug. If you do not know if your prescription drug contains MAOI, ask a doctor or pharmacist before taking this product.
When Using This Product
  • excitability may occur, especially in children
  • may cause drowsiness
  • alcohol, 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
  • symptoms do not improve within 7 days or are accompanied by fever
  • new symptoms occur
Ask A Doctor Before Use If You Have
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes melitus
  • difficulty in urination due to enlargement of the prostate gland

Structured Label Content

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
  • nasal congestion
  • reduces swelling of nasal passages
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

Section 50568-5 (50568-5)

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

Section 51945-4 (51945-4)

Add image transcription here...

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)
Active Ingredients

(in each immediate-release tablet)
Purpose
Chlorcyclizine HCl 25 mg Antihistamine
Pseudoephedrine HCl 60 mg Nasal Decongestant
Warnings

Do not exceed recommended dosage.

Directions

Do not exceed recommended dosage.

Adults and children 12 years of age and over: 1 tablet by mouth every 6-8 hours, not to exceed 3 tablets in 24 hours, or as directed by a doctor
Children 6 to under 12 years of age: ½ tablet by mouth every 6-8 hours, not to exceed 1½ tablets in 24 hours, or as directed by a doctor
Children under 6 years of age Consult a doctor
Inactive Ingredients (Inactive ingredients)

Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate

Questions Or Comments? (Questions or Comments?)

Call 1-888-206-5525 • www.magnaweb.com

Do Not Use This Product (Do not use this product)
  • If you are taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for two weeks after stopping the MAOI drug. If you do not know if your prescription drug contains MAOI, ask a doctor or pharmacist before taking this product.
When Using This Product (When using this product)
  • excitability may occur, especially in children
  • may cause drowsiness
  • alcohol, 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 (Stop use and ask a doctor if)
  • nervousness, dizziness or sleeplessness occur
  • symptoms do not improve within 7 days or are accompanied by fever
  • new symptoms occur
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
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes melitus
  • difficulty in urination due to enlargement of the prostate gland

Advanced Ingredient Data


Raw Label Data

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