Chlo Tuss

Chlo Tuss
SPL v9
SPL
SPL Set ID 43610aaa-8b94-40d5-ae09-3d75bd2317c8
Route
ORAL
Published
Effective Date 2024-03-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlophedianol (12.5 mg) Dexbrompheniramine (1 mg) Pseudoephedrine (30 mg)
Inactive Ingredients
Citric Acid Monohydrate Glycerin Propylene Glycol Water Sodium Citrate Saccharin Sodium Sorbitol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-10-01

Description

Active ingredients (in each 5 mL teaspoonful) Chlophedianol Hydrochloride 12.5 mg Dexbrompheniramine Maleate 1 mg Pseudoephedrine Hydrochloride 30 mg

Purpose

Cough Suppressant Antihistamine Nasal Decongestant


Medication Information

Purpose

Cough Suppressant

Antihistamine

Nasal Decongestant

Description

Active ingredients (in each 5 mL teaspoonful) Chlophedianol Hydrochloride 12.5 mg Dexbrompheniramine Maleate 1 mg Pseudoephedrine Hydrochloride 30 mg

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.

Directions

Do not exceed recommended dosage.

 

 Adults and children

12 years of age and over:

2 teaspoonfuls (10 mL)

every 6 hours, not to

exceed 8 teaspoonfuls

in 24 hours 

Children 6 to under

12 years of age: 

1 teaspoonful (5 mL)

every 6 hours, not to

exceed 4 teaspoonfuls

in 24 hours 

Children under

6 years of age: 

Consult a doctor 

 

Drug Facts

Active ingredients

(in each 5 mL teaspoonful)

Chlophedianol Hydrochloride 12.5 mg

Dexbrompheniramine Maleate 1 mg

Pseudoephedrine Hydrochloride 30 mg

Other Information

Store at 59° - 86°F (15° - 30°C)

Product Packaging

Inactive Ingredients

Citric Acid, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol, Tutti Frutti Flavor.

Questions? Comments?

Serious side effects associated with use of this product may be reported to this number. Call 1-423-493-9170

(8 a.m. to 5 p.m.)

Do Not Use This Product
  • 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

When Using This Product
  • excitability may occur, especially in children
  • may cause marked drowsiness
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase the drowsiness effect
  • be careful when driving a motor vehicle or operating machinery
Stop Use and Ask A Doctor If
  • nervousness, dizziness, or sleeplessness occur
  • cough or nasal congestion persists for more than 1 week, tends to recur, or is 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 A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers.


Structured Label Content

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



Purpose

Cough Suppressant

Antihistamine

Nasal Decongestant

Warnings

Do not exceed recommended dosage.

Directions

Do not exceed recommended dosage.

 

 Adults and children

12 years of age and over:

2 teaspoonfuls (10 mL)

every 6 hours, not to

exceed 8 teaspoonfuls

in 24 hours 

Children 6 to under

12 years of age: 

1 teaspoonful (5 mL)

every 6 hours, not to

exceed 4 teaspoonfuls

in 24 hours 

Children under

6 years of age: 

Consult a doctor 

 

Drug Facts

Active ingredients

(in each 5 mL teaspoonful)

Chlophedianol Hydrochloride 12.5 mg

Dexbrompheniramine Maleate 1 mg

Pseudoephedrine Hydrochloride 30 mg

Other Information (Other information)

Store at 59° - 86°F (15° - 30°C)

Product Packaging (PRODUCT PACKAGING)

Inactive Ingredients (Inactive ingredients)

Citric Acid, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol, Tutti Frutti Flavor.

Questions? Comments?

Serious side effects associated with use of this product may be reported to this number. Call 1-423-493-9170

(8 a.m. to 5 p.m.)

Do Not Use This Product (Do not use this product)
  • 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

When Using This Product (When using this product)
  • excitability may occur, especially in children
  • may cause marked drowsiness
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase the drowsiness effect
  • 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 occur
  • cough or nasal congestion persists for more than 1 week, tends to recur, or is 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 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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