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Drug Facts

Composition & Product

Active Ingredients

chlophedianol (12.5 mg) pyrilamine (30 mg) pseudoephedrine

Inactive Ingredients

citric acid acetate glycerin propylene glycol sodium benzoate sodium citrate sucralose water

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2017-08-16

Medication Information

Purpose

Antitussive

Antihistamine

Nasal Decongestant

Directions

Do not exceed recommended dosage.

Adults and Children 12 Years or Older.	5-10ml (1-2 tsp) every 6 to 8 hours not to exceed 40ml in 24hr
Children 6-12	5ml (1 tsp) every 6 to 8 hours not to exceed 20ml in 24hr
Children under 6 years of age	Consult a doctor.

Other Information

Store at 59° - 85° F (15° - 30° C)

Inactive Ingredients

Citric Acid, Glycerin, Natural & Artificial Flavors, Propylene Glycol, Sodium Benzoate, Sodium Citrate, Sucralose, Water

Description

Active Ingredients (in each 5 mL (1 tsp)) Purpose Chlophedianol HCl 12.5 mg...........................Cough Suppressant Pyrilamine Maleate 12.5 mg...........................Antihistamine Pseudoephedrine HCl 30 mg...........................Nasal Decongestant

Principal Display Panel

uses:

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

Cough due to minor throat and bronchial irritation
Runny Nose
Sneezing
Itching of the nose or throat
Itchy, watery eyes
Nasal Congestion
Reduces swelling of nasal passages

warnings

Do not exceed recommended dosage

Do not use this product if

you are now taking 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.

drug Facts

Active Ingredients (in each 5 mL (1 tsp)) Purpose

Chlophedianol HCl 12.5 mg...........................Cough Suppressant

Pyrilamine Maleate 12.5 mg...........................Antihistamine

Pseudoephedrine HCl 30 mg...........................Nasal Decongestant

Questions? Comments?

To report a serious adverse event or obtain product information, contact 1-866-959-4880

When Using This Product

excitability may occur, especially in children
marked drowsiness may occur
avoid alcoholic beverages
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,
rash, or persistent headache. A persistent cough may be a sign of a serious condition
new symptoms occur

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 right away.

Ask A Doctor Before Use If You Have

a cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema
a cough that occurs with too much phlegm (mucus)
a breathing problem such as emphysema or chronic bronchitis
glaucoma
trouble urinating due to an enlarged prostate gland
heart disease
high blood pressure
thyroid disease
diabetes

Ask Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers

Structured Label Content

Purpose

Antitussive

Antihistamine

Nasal Decongestant

Directions

Do not exceed recommended dosage.

Adults and Children 12 Years or Older.	5-10ml (1-2 tsp) every 6 to 8 hours not to exceed 40ml in 24hr
Children 6-12	5ml (1 tsp) every 6 to 8 hours not to exceed 20ml in 24hr
Children under 6 years of age	Consult a doctor.

Other Information

Store at 59° - 85° F (15° - 30° C)

Inactive Ingredients

Citric Acid, Glycerin, Natural & Artificial Flavors, Propylene Glycol, Sodium Benzoate, Sodium Citrate, Sucralose, Water

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

uses: (Uses:)

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

Cough due to minor throat and bronchial irritation
Runny Nose
Sneezing
Itching of the nose or throat
Itchy, watery eyes
Nasal Congestion
Reduces swelling of nasal passages

warnings (WARNINGS)

Do not exceed recommended dosage

Do not use this product if

you are now taking 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.

drug Facts (Drug Facts)

Active Ingredients (in each 5 mL (1 tsp)) Purpose

Chlophedianol HCl 12.5 mg...........................Cough Suppressant

Pyrilamine Maleate 12.5 mg...........................Antihistamine

Pseudoephedrine HCl 30 mg...........................Nasal Decongestant

Questions? Comments?

To report a serious adverse event or obtain product information, contact 1-866-959-4880

When Using This Product (When using this product)

excitability may occur, especially in children
marked drowsiness may occur
avoid alcoholic beverages
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful 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 occurs
symptoms do not improve within 7 days or are accompanied by a fever,
rash, or persistent headache. A persistent cough may be a sign of a serious condition
new symptoms occur

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 right away.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

a cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema
a cough that occurs with too much phlegm (mucus)
a breathing problem such as emphysema or chronic bronchitis
glaucoma
trouble urinating due to an enlarged prostate gland
heart disease
high blood pressure
thyroid disease
diabetes

Ask Doctor Or Pharmacist Before Use If You Are (Ask doctor or pharmacist before use if you are)

taking sedatives or tranquilizers

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Purpose": "Antitussive Antihistamine Nasal Decongestant", "Uses:": "Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies. Cough due to minor throat and bronchial irritation Runny Nose Sneezing Itching of the nose or throat Itchy, watery eyes Nasal Congestion Reduces swelling of nasal passages", "Directions": "Do not exceed recommended dosage. Adults and Children 12 Years or Older. 5-10ml (1-2 tsp) every 6 to 8 hours not to exceed 40ml in 24hr Children 6-12 5ml (1 tsp) every 6 to 8 hours not to exceed 20ml in 24hr Children under 6 years of age Consult a doctor.", "WARNINGS": "Do not exceed recommended dosage Do not use this product if you are now taking 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.", "Drug Facts": "Active Ingredients (in each 5 mL (1 tsp)) Purpose Chlophedianol HCl 12.5 mg...........................Cough Suppressant Pyrilamine Maleate 12.5 mg...........................Antihistamine Pseudoephedrine HCl 30 mg...........................Nasal Decongestant", "Other Information": "Store at 59° - 85° F (15° - 30° C)", "Inactive Ingredients": "Citric Acid, Glycerin, Natural & Artificial Flavors, Propylene Glycol, Sodium Benzoate, Sodium Citrate, Sucralose, Water", "Questions? Comments?": "To report a serious adverse event or obtain product information, contact 1-866-959-4880", "When using this product": "excitability may occur, especially in children marked drowsiness may occur avoid alcoholic beverages 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, rash, or persistent headache. A persistent cough may be a sign of a serious condition new symptoms occur", "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 right away.", "Ask a doctor before use if you have": "a cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema a cough that occurs with too much phlegm (mucus) a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland heart disease high blood pressure thyroid disease diabetes", "Ask doctor or pharmacist before use if you are": "taking sedatives or tranquilizers"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information