Deltuss Dmx Cough Suppressant Nasal Decongestant Antihistamine Grape Flavor

Deltuss Dmx Cough Suppressant Nasal Decongestant Antihistamine Grape Flavor
SPL v6
SPL
SPL Set ID 783eaa30-c889-48e9-8ac6-22d3fecc84c8
Route
ORAL
Published
Effective Date 2015-08-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dexchlorpheniramine (1 mg) Dextromethorphan (15 mg) Pseudoephedrine (30 mg)
Inactive Ingredients
Anhydrous Citric Acid Glycerin Propylene Glycol Water Sodium Citrate Saccharin Sodium Sorbitol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2015-03-20

Description

Dexchlorpheniramine maleate, USP 1 mg Dextromethorphan HBr, USP 15 mg Pseudoephedrine HCl, USP 30 mg

Purpose

Antihistamine Cough suppressant Nasal Decongestant


Medication Information

Purpose

Antihistamine



Cough suppressant



Nasal Decongestant

Description

Dexchlorpheniramine maleate, USP 1 mg Dextromethorphan HBr, USP 15 mg Pseudoephedrine HCl, USP 30 mg

Uses
  • temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold or inhaled irritants
  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • Temporarily relieves these symptoms due to hay fever (allergic rhinitis):
  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes
  • Temporarily restores freer breathing through the nose
Section 50570-1

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.

Warnings



Directions


  • use only with enclosed measuring cup
  • do not use enclosed measuring cup for any other drug product
Adults and children 12 years of age and older:

2 teaspoonfuls (tsp) every 6 hours not to exceed 8 teaspoonfuls in 24 hours, or as directed by a doctor.

Children 6 to under 12 years of age:

1 teaspoonful (tsp) every 6 hours not to exceed 4 teaspoonfuls in 24 hours, or as directed by a doctor.

Children 2 to under 6 years of age:

Consult a doctor.

Drug Facts



Questions?

Call 1-787-701-3312. You may also report serious side effects to this phone number.

Product Labels

Other Information
  • Store at room temperature 15°C-30°C (59°F-86°F)

Inactive Ingredients

Bitter Mask, Citric Acid Anhydrous, Glycerin, Grape Flavor, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol.

When Using This Product
  • do not exceed recommended dosage
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase the drowsiness effect
  • avoid alcoholic beverages
  • use caution when driving a motor vehicle or operating machinery
  • excitability may occur especially in children

Ask A Doctor Before Use If

you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlarged prostrate gland
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough accompanied by excessive phlegm (mucus)

If Pregnant Or Breastfeeding

ask a health professional before use.

Stop Use and Ask A Doctor If
  • cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
  • symptoms do not improve within 7 days or are accompanied by fever
  • nervousness, dizziness, or sleeplessness occur

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Active Ingredients(in Each 5 Ml Teaspoonful)

Dexchlorpheniramine maleate, USP 1 mg

Dextromethorphan HBr, USP 15 mg

Pseudoephedrine HCl, USP 30 mg

Ask A Doctor Or Pharmacist Before Use If You Are Taking Sedatives Or Tranquilizers




Structured Label Content

Uses
  • temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold or inhaled irritants
  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • Temporarily relieves these symptoms due to hay fever (allergic rhinitis):
  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes
  • Temporarily restores freer breathing through the nose
Section 50570-1 (50570-1)

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.

Purpose

Antihistamine



Cough suppressant



Nasal Decongestant

Warnings



Directions


  • use only with enclosed measuring cup
  • do not use enclosed measuring cup for any other drug product
Adults and children 12 years of age and older:

2 teaspoonfuls (tsp) every 6 hours not to exceed 8 teaspoonfuls in 24 hours, or as directed by a doctor.

Children 6 to under 12 years of age:

1 teaspoonful (tsp) every 6 hours not to exceed 4 teaspoonfuls in 24 hours, or as directed by a doctor.

Children 2 to under 6 years of age:

Consult a doctor.

Drug Facts



Questions?

Call 1-787-701-3312. You may also report serious side effects to this phone number.

Product Labels

Other Information (Other information)
  • Store at room temperature 15°C-30°C (59°F-86°F)

Inactive Ingredients (Inactive ingredients)

Bitter Mask, Citric Acid Anhydrous, Glycerin, Grape Flavor, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol.

When Using This Product (When using this product)
  • do not exceed recommended dosage
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase the drowsiness effect
  • avoid alcoholic beverages
  • use caution when driving a motor vehicle or operating machinery
  • excitability may occur especially in children

Ask A Doctor Before Use If (Ask a doctor before use if)

you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlarged prostrate gland
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough accompanied by excessive phlegm (mucus)

If Pregnant Or Breastfeeding (If pregnant or breastfeeding)

ask a health professional before use.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
  • symptoms do not improve within 7 days or are accompanied by fever
  • nervousness, dizziness, or sleeplessness occur

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.

Active Ingredients(in Each 5 Ml Teaspoonful) (Active ingredients(in each 5 mL teaspoonful))

Dexchlorpheniramine maleate, USP 1 mg

Dextromethorphan HBr, USP 15 mg

Pseudoephedrine HCl, USP 30 mg

Ask A Doctor Or Pharmacist Before Use If You Are Taking Sedatives Or Tranquilizers (Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers)




Advanced Ingredient Data


Raw Label Data

All Sections (JSON)