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NDC 63102-0104-16 ACTINEL DM 20; 400; 10 mg/5mL; mg/5mL; mg/5mL Details
ACTINEL DM 20; 400; 10 mg/5mL; mg/5mL; mg/5mL
ACTINEL DM is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Actipharma, Inc. The primary component is DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.
Related Packages: 63102-0104-16Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Dextromethorphan
Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.
Related Packages: 63102-0104-16Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Guaifenesin
Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.
Related Packages: 63102-0104-16Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 63102-0104 |
|---|---|
| Product ID | 63102-104_7ee7ae4e-b359-4c71-8cd6-d12ed54e5158 |
| Associated GPIs | 43997303100980 |
| GCN Sequence Number | 066799 |
| GCN Sequence Number Description | guaifen/dextromethorphan/PE LIQUID 400-20-10 ORAL |
| HIC3 | B4R |
| HIC3 Description | NON-OPIOID ANTITUSSIVE-DECONGESTANT-EXPECTORANT |
| GCN | 29196 |
| HICL Sequence Number | 000216 |
| HICL Sequence Number Description | GUAIFENESIN/DEXTROMETHORPHAN HBR/PHENYLEPHRINE |
| Brand/Generic | Generic |
| Proprietary Name | ACTINEL DM |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 20; 400; 10 |
| Active Ingredient Units | mg/5mL; mg/5mL; mg/5mL |
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | Actipharma, Inc |
| Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 63102-0104-16 (63102010416)
| NDC Package Code | 63102-104-16 |
|---|---|
| Billing NDC | 63102010416 |
| Package | 474 mL in 1 BOTTLE, PLASTIC (63102-104-16) |
| Marketing Start Date | 2019-05-20 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 16660d82-524b-42ca-8581-48237caa13b2 Details
Active Ingredients (in each 5 mL tsp)
Uses
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 • diabetes • heart disease • thyroid disease • high blood pressure • trouble urinating due to an enlarged prostate gland • cough that occurs with too much phlegm (mucus) • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.
When using this product • do not exceed recommended dosage
Stop use and ask a doctor if • you get nervous, dizzy, or sleepless • symptoms do not get better within 7 days or are accompanied by fever • coughs lasts more than 7 days, come back, or is accompanied by fever, rash, or a persistent headache. These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
Directions
Other information
• Store at room temperature 15°- 30°C (59°- 86°F) • protect from freezing • protect from light • Avoid excessive heat or humidity. TAMPER EVIDENT: Do not use if inner seal is torn, broken or missing. Pharmacist: Preserve and dispense in tight, light-resistant container with a child resistant cap as defined in the USP.
Inactive ingredients:
SPL UNCLASSIFIED SECTION
Contains the same active ingredients as Tusnel® DM*
SUGAR FREE
DYE FREE
ALCOHOL FREE
Great Flavor
Manufactured in the USA for ActiPharma, Inc. Dorado, PR 00646. Tel: (787)608-0882
* Tusnel® DM is a registered trademark of Llorens Pharmaceutical. This product is not manufactured, distributed or marketed by Llorens Pharmaceutical.
INGREDIENTS AND APPEARANCE
| ACTINEL DM
dextromethorphan hbr, guaifenesin, phenylephrine hcl solution |
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| Labeler - Actipharma, Inc (079340948) |