Westussin Dm

Westussin Dm
SPL v5
SPL
SPL Set ID 68a0cd44-3fdd-430e-af1a-498d4415ab78
Route
ORAL
Published
Effective Date 2024-07-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dexchlorpheniramine (1 mg) Dextromethorphan (10 mg) Phenylephrine (5 mg)
Inactive Ingredients
Anhydrous Citric Acid Glycerin Propylene Glycol Water Sodium Benzoate Sodium Citrate, Unspecified Form Sorbitol Sucralose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-07-29

Description

Drug Facts


Medication Information

Description

Drug Facts

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 respiratory allergies
  • temporarily relieves these symptoms due to hay fever (allergic rhinitis):
  • runny nose
  • sneezing
  • itching of the nose of throat
  • itchy, watery eyes
  • temporarily restores freer breathing through the nose
Section 42229-5

Drug Facts

Section 50565-1

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

Section 50568-5

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

Section 50570-1

Do not use 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

Section 53414-9

If pregnant or breastfeeding ask a health professional before use

Section 55105-1
Active ingredients (in each 5 mL teaspoonful) Purpose
Dexchlorpheniramine Maleate 1 mg Antihistamine
Dextromethorphan HBr 10 mg Cough Suppressant
Phenylephrine HCl 5 mg Nasal Decongestant
Directions
Adults 12 and over: 10 mL every 4 hours Not to exceed 60 mL in 24hrs
Children 6-12: 5 mL every 4 hours Not to exceed 30 mL in 24hrs
Children 2-6: Consult a doctor
Questions?

Call weekdays from 9 AM to 5 PM EST at 1-844-221-7294. You may also report serious side effects to this phone number.

Other Information

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

Inactive Ingredients

Citric acid anhydrous, cotton candy flavoring, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol solution, sucralose.

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
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
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 prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma or emphysema
  • cough accompanied by excessive phlegm (mucus)
Principal Display Panel 480 Ml Bottle Label

NDC 69367-334-16

WesTussin DM

Antihistamine • Cough Suppressant

Nasal Decongestant

• Alcohol Free • Dye Free

• Sugar Free • Gluten Free

Each 5 mL (1 teaspoonful) contains:

Dexchlorpheniramine Maleate

1 mg

Dextromethorphan HBr

10 mg

Phenylephrine HCl

5 mg

Cotton Candy Flavor

TAMPER EVIDENT: Tamper evident by foil

seal under cap. Do not use if foil seal is

broken or missing.

16 oz (480 mL)

Westminster

Pharmaceuticals


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 respiratory allergies
  • temporarily relieves these symptoms due to hay fever (allergic rhinitis):
  • runny nose
  • sneezing
  • itching of the nose of throat
  • itchy, watery eyes
  • temporarily restores freer breathing through the nose
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50568-5 (50568-5)

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

Section 50570-1 (50570-1)

Do not use 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

Section 53414-9 (53414-9)

If pregnant or breastfeeding ask a health professional before use

Section 55105-1 (55105-1)
Active ingredients (in each 5 mL teaspoonful) Purpose
Dexchlorpheniramine Maleate 1 mg Antihistamine
Dextromethorphan HBr 10 mg Cough Suppressant
Phenylephrine HCl 5 mg Nasal Decongestant
Directions
Adults 12 and over: 10 mL every 4 hours Not to exceed 60 mL in 24hrs
Children 6-12: 5 mL every 4 hours Not to exceed 30 mL in 24hrs
Children 2-6: Consult a doctor
Questions?

Call weekdays from 9 AM to 5 PM EST at 1-844-221-7294. You may also report serious side effects to this phone number.

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

Citric acid anhydrous, cotton candy flavoring, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol solution, sucralose.

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
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
Ask A Doctor Before Use If You Have (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 prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma or emphysema
  • cough accompanied by excessive phlegm (mucus)
Principal Display Panel 480 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 480 mL Bottle Label)

NDC 69367-334-16

WesTussin DM

Antihistamine • Cough Suppressant

Nasal Decongestant

• Alcohol Free • Dye Free

• Sugar Free • Gluten Free

Each 5 mL (1 teaspoonful) contains:

Dexchlorpheniramine Maleate

1 mg

Dextromethorphan HBr

10 mg

Phenylephrine HCl

5 mg

Cotton Candy Flavor

TAMPER EVIDENT: Tamper evident by foil

seal under cap. Do not use if foil seal is

broken or missing.

16 oz (480 mL)

Westminster

Pharmaceuticals


Advanced Ingredient Data


Raw Label Data

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