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

Polytussin DM by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

(in each 5 mL teaspoonful)

Dextromethorphan HBr............... 7.5 mg
Phenylephrine HCl....................... 5 mg
Pyrilamine Maleate................. 12.5 mg

ASK DOCTOR/PHARMACIST

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

INDICATIONS & USAGE

Uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

• runny nose
• sneezing
• itching of nose or throat
• itchy, watery eyes
• cough due to minor throat and bronchial irritation
• nasal congestion
• reduces swelling of nasal passages

WARNINGS

Warnings

Do not exceed recommended dosage.

ASK DOCTOR

Ask a doctor before use if you have

• a breathing problem such as emphysema or chronic bronchitis
• glaucoma
• trouble urinating due to an enlarged prostate gland
• a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
• a cough that occurs with too much phlegm (mucus)
• heart disease
• high blood

WHEN USING

When using this product

• excitability may occur, especially in children
• may cause marked drowsiness
• avoid alcoholic drinks
• alcohol, sedatives, and tranquilizers may increase the drowsiness effect
• be careful when driving a motor vehicle or operating machinery

STOP USE

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur
• cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.
• new symptoms 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? Comments? Serious side effects associated with use of this product may be reported to this number. Call 1-800-882-1041
Mon. - Fri. (8 a.m. to 5 p.m. CST).

INACTIVE INGREDIENT

Inactive ingredients

Citric Acid, Flavor, Methylparaben, Potassium Citrate, Propylene Glycol, Propylparaben, Purified water, Sucralose,Sorbitol

PURPOSE

Antihistamine

Cough Suppressant

Nasal Decongestant

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

POLYTUSSIN DM 
dextromethorphan hbr, phenylephrine hcl, pyrilamine maleate syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50991-132
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	7.5 mg  in 5 mL
PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL)	PYRILAMINE MALEATE	12.5 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)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SUCRALOSE (UNII: 96K6UQ3ZD4)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

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: 50991-132-16	480 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/08/2023
2	NDC: 50991-132-15	15 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/08/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	06/08/2023

Labeler - Poly Pharmaceuticals, Inc. (198449894)