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  5. Label Information: Westussin Dm

FDA Label for Westussin Dm

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - PURPOSE
    3. USES
    4. OTC - DO NOT USE
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. OTC - ASK DOCTOR/PHARMACIST
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR IF
    9. OTC - PREGNANCY OR BREAST FEEDING
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS?
    15. PRINCIPAL DISPLAY PANEL - 480 ML BOTTLE LABEL

Westussin Dm Product Label

The following document was submitted to the FDA by the labeler of this product Westminster Pharmaceuticals, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts


Otc - Purpose



Active ingredients (in each 5 mL teaspoonful)Purpose
Dexchlorpheniramine Maleate 1 mgAntihistamine
Dextromethorphan HBr 10 mgCough Suppressant
Phenylephrine HCl 5 mgNasal Decongestant

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

Otc - Do Not Use



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


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)

Otc - Ask Doctor/Pharmacist



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


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

Otc - Pregnancy Or Breast Feeding



If pregnant or breastfeeding ask a health professional before use


Otc - 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.


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

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.


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.


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

PRINCIPAL DISPLAY PANEL - 480 mL Bottle Label - westussin 01

PRINCIPAL DISPLAY PANEL - 480 mL Bottle Label - westussin 01


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