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NDC 76117-0001-16 Rycontuss 2; 10; 5 mg/5mL; mg/5mL; mg/5mL Details
Rycontuss 2; 10; 5 mg/5mL; mg/5mL; mg/5mL
Rycontuss is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Okendpharma, Inc.. The primary component is CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Chlorpheniramine relieves red, itchy, watery eyes; sneezing; itchy nose or throat; and runny nose caused by allergies, hay fever, and the common cold. Chlorpheniramine helps control the symptoms of cold or allergies but will not treat the cause of the symptoms or speed recovery. Chlorpheniramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.
Related Packages: 76117-0001-16Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Chlorpheniramine
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: 76117-0001-16Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Dextromethorphan
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: 76117-0001-16Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 76117-0001 |
|---|---|
| Product ID | 76117-001_97b756b2-7fa2-fc74-e053-2995a90a4588 |
| Associated GPIs | 43995803120905 |
| GCN Sequence Number | 047004 |
| GCN Sequence Number Description | chlorpheniramine/phenyleph/DM LIQUID 2-5-10MG/5 ORAL |
| HIC3 | B3R |
| HIC3 Description | NON-OPIOID ANTITUS-1ST GEN.ANTIHISTAMINE-DECONGEST |
| GCN | 85914 |
| HICL Sequence Number | 000375 |
| HICL Sequence Number Description | CHLORPHENIRAMINE MALEATE/PHENYLEPHRINE HCL/DEXTROMETHORPHAN |
| Brand/Generic | Generic |
| Proprietary Name | Rycontuss |
| Proprietary Name Suffix | Cherry Flavor |
| Non-Proprietary Name | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LIQUID |
| Route | ORAL |
| Active Ingredient Strength | 2; 10; 5 |
| Active Ingredient Units | mg/5mL; mg/5mL; mg/5mL |
| Substance Name | CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | Okendpharma, Inc. |
| Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Rece |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 76117-0001-16 (76117000116)
| NDC Package Code | 76117-001-16 |
|---|---|
| Billing NDC | 76117000116 |
| Package | 473 mL in 1 BOTTLE (76117-001-16) |
| Marketing Start Date | 2011-05-31 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL c91798fa-48ab-47a0-92da-4d44c2aafde0 Details
SPL UNCLASSIFIED SECTION
Active ingredients Purpose
Chlorpheniramine Maleate 2mg............................................................Antihistamine
Dextromethorphan Hydrobromide 10mg.........................................Cough Supressant
Phenylephrine Hydrochloride 5mg...............................................Nasal Decongestant
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Warnings Do not use - To sedate a child or to make a child sleepy. - If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psyquiatric or emotional condition, or for 2 weeks after stopping the MAOI drug. - If you do not know if your prescription drug contains a MAOI, ask a doctor or pharmacist before taking this product.
SPL UNCLASSIFIED SECTION
Ask a doctor before use if you have - Heart disease. - Thyroid disease. - Trouble urinating due to enlarged prostate gland. - Glaucoma. - Cough that occurs with too much phlegm (mucus). - Breathing problems or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis or emphysema.
SPL UNCLASSIFIED SECTION
When using this product - Do not use more than directed. - May cause marked drowsiness. - Avoid alcoholic beverages. - Alcohol, sedatives and tranquilizers may cause increased drowsiness. - Be careful when driving a motor vehicle or operating machinery. - Excitability may occur, especially with children.
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
| RYCONTUSS
CHERRY FLAVOR
chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid |
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| Labeler - Okendpharma, Inc. (832814276) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Dextrum Laboratories Inc. | 007392322 | manufacture(76117-001) | |