FDA Label for Bio-rytuss
View Indications, Usage & Precautions
Bio-rytuss Product Label
The following document was submitted to the FDA by the labeler of this product Advanced Generic Corporation. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredients (in each 5 mL tsp.) Purpose
Chlorpheniramine Maleate 2 mg Antihistamine
Dextromethorphan Hydrobromide 10 mg Cough Suppressant
Phenylephrine Hydrochloride 5 mg Nasal Decongestant
Otc - Purpose
Purpose
Antihistamine
Cough Suppressant
Nasal Decongestant
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
- 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.
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
Otc - 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 Stop use and ask a doctor if you
- 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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center immediately
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding,ask a doctor before use
Dosage & Administration
Directions do not take more than 6 doses in any 24 hour period
| adults and children 12 years of age | 2 teaspoonful (10 mL) every 4-6 hours |
| children 6 to under 12 years of age | 1 teaspoonful (5 mL) every 4-6 hours |
| children 2 to under 6 years of age | 1/2 teaspoonful (2.5 mL) every 4-6 hours |
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
Inactive ingredients
Citric acid, FD&C Red #40, flavor, methylparaben, propylene glycol, propylparaben, purified water, Sodium citrate, sucralose.
Otc - Questions
Questions or comments?
1-305-403-3788
Package Label.Principal Display Panel
* Please review the disclaimer below.