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Drug Facts
Westussin Dm Syrup
FDA Label NDC 69367-334
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Westminster Pharmaceuticals, Llc for the product Westussin Dm (NDC 69367-334). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - purpose, uses, otc - do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| 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 |
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)
* Please review the disclaimer below.
