NDC | 45737-250-16 |
Set ID | e48e46e3-d3fa-4b25-8b07-bbecc4f0b64b |
Category | HUMAN OTC DRUG LABEL |
Packager | Advanced Generic Corporation |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- ACTIVE INGREDIENT
- PURPOSE
-
WARNINGS
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.
-
DO NOT USE
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.
- KEEP OUT OF REACH OF CHILDREN
- PREGNANCY OR BREAST FEEDING
- DOSAGE & ADMINISTRATION
-
INDICATIONS & USAGE
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.
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
BIO-RYTUSS
chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:45737-250 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 2 mg in 5 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 5 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg in 5 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) SODIUM CITRATE (UNII: 1Q73Q2JULR) SUCRALOSE (UNII: 96K6UQ3ZD4) FD&C RED NO. 40 (UNII: WZB9127XOA) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) Product Characteristics Color Score Shape Size Flavor CHERRY (cherry flavor) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:45737-250-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/01/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 08/01/2012 Labeler - Advanced Generic Corporation (831762971)