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NDC 45737-0250-16 BIO-RYTUSS 2; 10; 5 mg/5mL; mg/5mL; mg/5mL Details
BIO-RYTUSS 2; 10; 5 mg/5mL; mg/5mL; mg/5mL
BIO-RYTUSS is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Advanced Generic Corporation. 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: 45737-0250-16Last Updated: 11/30/2022
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: 45737-0250-16Last Updated: 11/30/2022
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: 45737-0250-16Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
NDC | 45737-0250 |
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Product ID | 45737-250_42971dd8-e7b7-4696-8082-158e4ee51e4e |
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 | BIO-RYTUSS |
Proprietary Name Suffix | n/a |
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 | Advanced Generic Corporation |
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 45737-0250-16 (45737025016)
NDC Package Code | 45737-250-16 |
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Billing NDC | 45737025016 |
Package | 473 mL in 1 BOTTLE (45737-250-16) |
Marketing Start Date | 2012-08-01 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL e48e46e3-d3fa-4b25-8b07-bbecc4f0b64b Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Warnings
Ask doctor before use if you have
- Cough that occurs with too much phlegm (mucus), or a breathing problem or persitent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis or emphysema.
- Heart disease
- High blood pressure
- Thyroid Disease
- Diabetes
- Difficulty in urinating due to enlarged prostate gland
- Glaucoma
Ask doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant; taking sedatives or tranquilizers.
When using this product
- Do not use more than directed
- May cause marked drowsiness; avoid alcohol beverages; alcohol, sedatives and tranquilizers may increase drowsiness.
- Be careful when driving a motor vehicle or operating machinery; excitability may occur, especially with children.
SPL UNCLASSIFIED SECTION
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, psychiatric, or emotional conditions or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if you are taking a prescription that contains an MAOI, ask your doctor or pharmacist before taking this product
- you get nervous, dizzy or sleepless
- symptoms do not get better within 7 days or are accompanied by fever
- cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headaches. These could be signs of a serious condition.
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Uses
- temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold, and 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; itchy watery eyes; itching of the nose or throat
- temporarily restores freer beathing through the nose.
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
BIO-RYTUSS
chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid |
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Labeler - Advanced Generic Corporation (831762971) |