WESTUSSIN DM- dexchlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl syrup

WesTussin DM by

Drug Labeling and Warnings

WesTussin DM by is a Otc medication manufactured, distributed, or labeled by Westminster Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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

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

INGREDIENTS AND APPEARANCE

WESTUSSIN DM 
dexchlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69367-334
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXCHLORPHENIRAMINE MALEATE (UNII: B10YD955QW) (DEXCHLORPHENIRAMINE - UNII:3Q9Q0B929N)	DEXCHLORPHENIRAMINE MALEATE	1 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	COTTON CANDY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69367-334-16	480 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/29/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M012	07/29/2021

Labeler - Westminster Pharmaceuticals, LLC (079516651)