RYCONTUSS CHERRY FLAVOR- chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid

Rycontuss by

Drug Labeling and Warnings

Rycontuss by is a Otc medication manufactured, distributed, or labeled by Okendpharma, Inc., Dextrum Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients                                                                                       Purpose
Chlorpheniramine Maleate 2mg............................................................Antihistamine
Dextromethorphan Hydrobromide 10mg.........................................Cough Supressant
Phenylephrine Hydrochloride 5mg...............................................Nasal Decongestant

PURPOSE

Uses  - For the temporary relief of runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever  - Temporarily relieves cough due to minor throat and bronchial irritation occurring with the common cold  - Temporarily restores freer breathing through the nose

WARNINGS

Warnings  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, psyquiatric or emotional condition, or for 2 weeks after stopping the MAOI drug. - If you do not know if your prescription drug contains a MAOI, ask a doctor or pharmacist before taking this product.

ASK DOCTOR

Ask a doctor before use if you have  - Heart disease.  - Thyroid disease.  - Trouble urinating due to enlarged prostate gland.  - Glaucoma.  - Cough that occurs with too much phlegm (mucus).  - Breathing problems or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis or emphysema.

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist if you are taking sedatives or tranquilizers.

WHEN USING

When using this product  - Do not use more than directed.  - May cause marked drowsiness.  - Avoid alcoholic beverages.  - Alcohol, sedatives and tranquilizers may cause increased drowsiness.  - Be careful when driving a motor vehicle or operating machinery.  - Excitability may occur, especially with children.

STOP USE

Stop use and ask a doctor if  - You get nervous, dizzy, or sleepless.  - Cough lasts more than 7 days, come back, or is accompanied by a fever, rash, or persistent headaches. These could be signs of a serious condition.  If pregnant or breast feeding ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

INDICATIONS & USAGE

In case of overdose, get medical help or contact a poison control center right away.

DOSAGE & ADMINISTRATION

• Adults and children 12 or older: 2 tsp (10 mL) every 4 hours
• Chidren age 6 - 12: 1 tsp (5 mL) every 4 hours
• Children younger than 6: Ask a doctor

STORAGE AND HANDLING

Other information  - Store at controlled room temperature between 15-30 C (58-86F)  - Avoid excessive heat or humidity.

INACTIVE INGREDIENT

Inactive Ingredients
Citric acid, DandC red #33, FDandC red #40, flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate and sucrose.

QUESTIONS

Questions or comments  Phone: 1-787-548-0016, Labor hours 8:00 am to 5:00 pm

DESCRIPTION

Manufactured for:  Okendpharma Inc,  4287 Constancia Ave. Villa Del Carmen Ponce, PR 00716  United States  Product of Puerto Rico

PRINCIPAL DISPLAY PANEL

NDC  RYCONTUSS Liquid  CHERRY FLAVOR  ANTITUSSIVE NASAL  DECONGESTANT AND ANTIHISTAMINE  16 fl oz (1 print) (473 ml)  Lot #  Exp.Date

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RYCONTUSS   CHERRY FLAVOR
chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76117-001
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)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 40 (UNII: WZB9127XOA)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY (CHERRY)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76117-001-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/31/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	05/31/2011

Labeler - Okendpharma, Inc. (832814276)

Establishment
Name	Address	ID/FEI	Business Operations
Dextrum Laboratories Inc.		007392322	manufacture(76117-001)