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

Polytussin DM by

Drug Labeling and Warnings

Polytussin DM by is a Otc medication manufactured, distributed, or labeled by Poly Pharmaceuticals, Inc., Monarch PCM LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

(in each 5 mL teaspoonful)

Dexchlorpheniramine Maleate 1 mg .............Antihistamine

Dextromethorphan HBr 10 mg ........... Cough Suppressant

Phenylephrine HCl 5 mg ....................Nasal Decongestant

ASK DOCTOR/PHARMACIST

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

INDICATIONS & USAGE

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 upper respiratory allergies
• Temporarily relieves these symptoms due to hay fever (allergic rhinitis):
• Runny nose
• sneezing
• itching of the nose or throat
• itchy, watery eyes
• Temporarily restores freer breathing through the nose

WARNINGS

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 DOCTOR

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 prostrate gland
• persistent or chronic cough such as occurs with smoking, asthma or emphysema
• cough accompanied by excessive phlegm (mucus)

WHEN USING

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

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

PREGNANCY OR BREAST FEEDING

If pregnant or breastfeeding ask a health professional before use

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

DOSAGE & ADMINISTRATION

Directions

Adults 12 and over: 10 mL every 4 hours

Not to exceed 60 mL in 24hours

Children 6-12: 5 mL every 4 hours,

Not to exceed 30 mL in 24hrs

Children 2-6: Consult a doctor

OTHER SAFETY INFORMATION

Other information

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

Questions? Call 1-800-882-1041. You may also report serious side effects to this phone number.

Professional Labeling

Take under guidance of Health Professionals.

Children 2-6 years of age: 2.5 mL every 4 hours, not to

exceed 15 mL in a 24 hour period.

Iss. 09/17

INACTIVE INGREDIENT

Inactive ingredients

Citric Acid Anhydrous, Cotton Candy, Glycerin, Propylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate Dihydrate, Sorbitol Solution, Sucralose.

PURPOSE

Antihistamine

Cough Suppressant

Nasal Decongestant

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

POLYTUSSIN DM 
dexchlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50991-492
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
SODIUM BENZOATE (UNII: OJ245FE5EU)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color		Score
Shape		Size
Flavor	COTTON CANDY (clear, colorless)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50991-492-16	480 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/22/2017
2	NDC: 50991-492-15	15 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/22/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	11/22/2017

Labeler - Poly Pharmaceuticals, Inc. (198449894)

Establishment
Name	Address	ID/FEI	Business Operations
Monarch PCM LLC		080000294	manufacture(50991-492)