BIO-RYTUSS- chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid

BIO-RYTUSS by

Drug Labeling and Warnings

BIO-RYTUSS by is a Otc medication manufactured, distributed, or labeled by Advanced Generic Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

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

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.

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

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 children12 years of age: 2 teaspoonful (10 mL); every 4-6 hours
• children 6 to under12 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.

QUESTIONS

Questions or comments?

1-305-403-3788

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BIO-RYTUSS 
chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid

Product 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)