Indications and uses
• helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes • temporarily relieves these symptoms occurring with a cold: • nasal congestion • cough due to minor throat and bronchial irritation
ACTINEL DM
- Manufacturer
- ACTIPHARMA, LLC
- Effective date
- 2024-06-28
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 00:16:52
Label at a glance#
ProductACTINEL DM
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections
Dosage and administration
take every 4 hours, or as directed by a doctor. AGE DOSE adults and children 12 years of age and over take 5mL (1tsp). Do not exceed 6 doses in 24 hours Children under 12 years of age ask a doctor
Storage and handling
• tamper evident feature: Do not use if safety seal is torn, broken or missing. • store at controlled room temperature 15 ° - 30 ° C (59 ° - 86 ° F). • avoid excessive heat or humidity.
Contacts and useful links#
Websitewww.actipharma.net
www.actipharma.net
www.actipharma.netLabel contents#
Full prescribing information#
Active ingredients (in each 5 mL tsp)
Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Phenylephrine HCl 10 mg
Purposes
Cough suppressant
Expectorant
Nasal decongestant
Uses
• helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
• temporarily relieves these symptoms occurring with a cold:
• nasal congestion • cough due to minor throat and bronchial irritation
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 a doctor before use if you have • heart disease • high blood pressure • thyroid disease • diabetes • difficulty in urination due to enlargement of the prostate gland • cough accompanied by excessive phlegm (mucus) • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema.
Ask a doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant.
When using this product do not exceed recommended dosage.
Stop use and ask a doctor if • nervousness, dizziness, or sleeplessness occur • symptoms do not improve within 7 days or are accompanied by fever • cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash or a persistent headache. A persistent cough may be a sign of a serious condition.
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.
Directions
- take every 4 hours, or as directed by a doctor.
| AGE | DOSE |
| adults and children 12 years of age and over | take 5mL (1tsp). Do not exceed 6 doses in 24 hours |
| Children under 12 years of age | ask a doctor |
Other information
• tamper evident feature: Do not use if safety seal is torn, broken or missing.
• store at controlled room temperature 15°- 30°C (59°- 86°F).
• avoid excessive heat or humidity.
Inactive ingredients
artificial and natural flavors, citric acid, glycerin, menthol, methylparaben, polyethylene glycol, propylparaben, purified water, sodium citrate, sucralose.
Questions or comments?
+1-787-608-0882
You may also report serious side effects to this phone number.
call weekdays from 8AM to 4PM AST
SPL UNCLASSIFIED SECTION
Contains the same active ingredients as Tusnel® DM*
• Alcohol FREE • Dye FREE
• Sugar FREE • Great Flavor
Manufactured in USA with imported ingredients for ActiPharma. San Juan, PR 00917. www.actipharma.net.
* Tusnel® DM is a registered trademark of Llorens Pharmaceutical. This product is not manufactured, distributed or marketed by Llorens Pharmaceutical.
Packaging
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1091331 | dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 5 mL Oral Solution | PSN | 2 |
| 1091331 | dextromethorphan hydrobromide 4 MG/ML / guaifenesin 80 MG/ML / phenylephrine hydrochloride 2 MG/ML Oral Solution | SCD | 2 |
| 1091331 | dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG / phenylephrine hydrochloride 10 MG per 5 ML Oral Solution | SY | 2 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63102-104-16 | ACTINEL DM | 474 mL in 1 BOTTLE, PLASTIC | SOLUTION | 474 | 2 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63102-104-16 | ML - Milliliter | 63102-104 | e5611555-7c2b-49cc-9617-59d35449879c | 1 | 2019-07-02 |
Products#
Every source-derived product name is available through these pages.
- ACTINEL DM
- Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- GUAIFENESIN
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- CITRIC ACID MONOHYDRATE
- GLYCERIN
- MENTHOL, UNSPECIFIED FORM
- METHYLPARABEN
- POLYETHYLENE GLYCOL 400
- PROPYLPARABEN
- WATER
- SODIUM CITRATE, UNSPECIFIED FORM
- SUCRALOSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 63102-104 | 63102-104-16 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| GUAIFENESIN | 495W7451VQ | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIM |
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| MENTHOL, UNSPECIFIED FORM | L7T10EIP3A | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM CITRATE, UNSPECIFIED FORM | 1Q73Q2JULR | 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 |
|---|---|---|---|---|---|---|
| ACTINEL DM | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | ACTIPHARMA, LLC | 16660d82-524b-42ca-8581-48237caa13b2 | 2024-06-28 | Warnings | 63102-104-16 63102-104 63102010416 a0ce93a6-b45b-4f6f-a9b6-4be407871774 16660d82-524b-42ca-8581-48237caa13b2 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.