Polytussin DM

Manufacturer
Poly Pharmaceuticals, Inc. | Monarch PCM LLC
Effective date
2020-01-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:44:35

Label at a glance#

ProductPolytussin DM
Active ingredientDEXCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure14 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

(in each 5 mL teaspoonful)

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

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

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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

INDICATIONS & USAGE SECTION

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 SECTION

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

OTC - ASK DOCTOR SECTION

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)

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

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 SECTION

If pregnant or breastfeeding ask a health professional before use

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away

DOSAGE & ADMINISTRATION SECTION

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 SECTION

Inactive ingredients

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

OTC - PURPOSE SECTION

Antihistamine

Cough Suppressant

Nasal Decongestant

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50991-492-16ML - Milliliter50991-49256f74bac-c5fa-4ad9-a222-b2cd7baa40f812018-01-12

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50991-49250991-492-16, 50991-492-15

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f4c8ac4d-60f4-2bef-e053-2a95a90aba1f5f006df2-adb9-3a60-e053-2a91aa0ab2062023-02-15WarningsExact identifier
spl set id: 5f006df2-adb9-3a60-e053-2a91aa0ab206

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.