WESTUSSIN DM- dexchlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl syrup 
Westminster Pharmaceuticals, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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WesTussin DM

Drug Facts

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

Uses

Warnings

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)

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

If pregnant or breastfeeding 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.

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 DM 
dexchlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69367-334
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXCHLORPHENIRAMINE MALEATE (UNII: B10YD955QW) (DEXCHLORPHENIRAMINE - UNII:3Q9Q0B929N) DEXCHLORPHENIRAMINE MALEATE1 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCOTTON CANDYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69367-334-16480 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/29/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/29/2021
Labeler - Westminster Pharmaceuticals, LLC (079516651)

Revised: 8/2021
Document Id: 08a5f7d6-6f1b-4d1c-8f06-1672bda7ea3a
Set id: 68a0cd44-3fdd-430e-af1a-498d4415ab78
Version: 1
Effective Time: 20210802
 
Westminster Pharmaceuticals, LLC