Polytussin DM
- Manufacturer
- Poly Pharmaceuticals, Inc. | BEO Pharma Inc | Belleview Bioscience LLC
- Effective date
- 2026-08-18
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 7
- Source
- daily-update
- Hydrated at
- 2026-08-21 02:01:41
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredients
(in each 5 mL teaspoonful)
Dextromethorphan HBr............... 7.5 mg
Phenylephrine HCl....................... 5 mg
Pyrilamine Maleate................. 12.5 mg
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 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 SECTION
Warnings
Do not exceed recommended dosage.
Do not use this product 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
- 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 pressure
- thyroid disease
- diabetes
OTC - WHEN USING SECTION
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
OTC - STOP USE SECTION
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
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, 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
Do not exceed recommended dosage.
Adults and children 12 years of age and over: 2 teaspoonfuls (10 mL) every 4 to 6 hours, not to exceed 12 teaspoonfuls in 24 hours
Children 6 to under 12 years of age:1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 6 teaspoonfuls in 24 hours
Children under 6 years of age: 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 SECTION
Inactive ingredients
Citric Acid, Flavor, Methylparaben, Potassium Citrate, Propylene Glycol, Propylparaben, Purified water, Sucralose, Sorbitol
OTC - PURPOSE SECTION
Antihistamine
Cough Suppressant
Nasal Decongestant
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0350991132168 | GTIN-13: 0350991132168 EAN-13: 0350991132168 GTIN-12: 350991132168 UPC-A: 350991132168 GTIN storage (14 digits): 00350991132168 | polytussinDM.jpg |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906 | Product name | 7 | 20210625 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50991-132-15 | 2025-12-09 | C162847 | 48780-1 | 3b156c62-2951-fb37-e063-e6dba90a4e07 | Polytussin DM |
| 50991-132-15 | 2025-12-09 | C162847 | 48780-1 | 3b156c62-2951-fb37-e063-e6dba90a4e07 | Polytussin DM |
| 50991-132-16 | 2025-12-09 | C162847 | 48780-1 | 3b156c62-2951-fb37-e063-e6dba90a4e07 | Polytussin DM |
| 50991-132-16 | 2025-12-09 | C162847 | 48780-1 | 3b156c62-2951-fb37-e063-e6dba90a4e07 | Polytussin DM |
| 50991-132-15 | 2025-07-29 | C162847 | 48780-1 | 3b156c62-2951-fb37-e063-e6dba90a4e07 | Polytussin DM |
| 50991-132-15 | 2025-07-29 | C162847 | 48780-1 | 3b156c62-2951-fb37-e063-e6dba90a4e07 | Polytussin DM |
| 50991-132-16 | 2025-07-29 | C162847 | 48780-1 | 3b156c62-2951-fb37-e063-e6dba90a4e07 | Polytussin DM |
| 50991-132-16 | 2025-07-29 | C162847 | 48780-1 | 3b156c62-2951-fb37-e063-e6dba90a4e07 | Polytussin DM |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50991-132-16 | ML - Milliliter | 50991-132 | d5683f16-5ffc-4d62-a4dc-fe97d1320250 | 1 | 2023-07-06 |
Products#
Every source-derived product name is available through these pages.
- Polytussin DM
- Dextromethorphan HBr, Phenylephrine HCl, Pyrilamine Maleate
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- PYRILAMINE MALEATE
- PYRILAMINE
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- ANHYDROUS CITRIC ACID
- SORBITOL
- WATER
- METHYLPARABEN
- PROPYLENE GLYCOL
- SUCRALOSE
- POTASSIUM CITRATE
- PROPYLPARABEN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50991-132 | 50991-132-16, 50991-132-15, 50991-132-05 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| PYRILAMINE MALEATE | R35D29L3ZA | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| SORBITOL | 506T60A25R | IACT |
| WATER | 059QF0KO0R | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| POTASSIUM CITRATE | EE90ONI6FF | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 6 | 2025-12-19 | full-release | 2026-06-01 01:27:34 |
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 |
|---|---|---|---|---|---|---|
| Polytussin DM | DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, PYRILAMINE MALEATE | Poly Pharmaceuticals, Inc. | fda8f594-82bf-1781-e053-6294a90ad344 | 2026-08-18 | Warnings | 50991-132-15 50991-132-16 50991-132-05 50991-132 50991013216 50991013205 50991013215 595703c9-b636-c1ee-e063-6294a90aa4a9 fda8f594-82bf-1781-e053-6294a90ad344 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
