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
The following Structured Product Label (SPL) was submitted to the FDA by Advanced Generic Corporation for the product Bio-rytuss (NDC 45737-250). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, otc - do not use, otc - keep out of reach of children, otc - pregnancy or breast feeding, dosage & administration, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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
Purpose
Antihistamine
Cough Suppressant
Nasal Decongestant
Warnings
Ask doctor before use if you have
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
Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center immediately
If pregnant or breast-feeding,ask a doctor before use
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 |
Uses
Inactive ingredients
Citric acid, FD&C Red #40, flavor, methylparaben, propylene glycol, propylparaben, purified water, Sodium citrate, sucralose.
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