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#
Contacts and useful links#
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
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50991-492-16 | ML - Milliliter | 50991-492 | 56f74bac-c5fa-4ad9-a222-b2cd7baa40f8 | 1 | 2018-01-12 |
Products#
Every source-derived product name is available through these pages.
- Polytussin DM
- DEXCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl
- SODIUM BENZOATE
- TRISODIUM CITRATE DIHYDRATE
- DEXCHLORPHENIRAMINE MALEATE
- DEXCHLORPHENIRAMINE
- ANHYDROUS CITRIC ACID
- SORBITOL
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- WATER
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- GLYCERIN
- PROPYLENE GLYCOL
- SUCRALOSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50991-492 | 50991-492-16, 50991-492-15 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| TRISODIUM CITRATE DIHYDRATE | B22547B95K | IACT |
| DEXCHLORPHENIRAMINE MALEATE | B10YD955QW | ACTIB |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| SORBITOL | 506T60A25R | IACT |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| WATER | 059QF0KO0R | IACT |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
| GLYCERIN | PDC6A3C0OX | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| f4c8ac4d-60f4-2bef-e053-2a95a90aba1f | 5f006df2-adb9-3a60-e053-2a91aa0ab206 | 2023-02-15 | Warnings | 5f006df2-adb9-3a60-e053-2a91aa0ab206 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
