Active Ingredient Section
ACTIVE INGREDIENT SECTION
CHLORPHENIRAMINE MALEATE 2MG
DEXTROMETHORPHAN HYDROBROMIDE 10MG
PHENYLEPHRINE HYDROCHLORIDE 5MG
Rycontuss Liquid
FDA Label NDC 65852-021
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dextrum Laboratories, Inc for the product Rycontuss (NDC 65852-021). 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 active ingredient section, inactive ingredient section, ask a doctor section, do not use section, keep out of reach of children section., pregnancy or breast feeding section, purpose section, question section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient Section
INACTIVE INGREDIENT SECTION:
CITRIC ACID, D&C RED#33, FD&C RED#40, NATURAL FLAVOR, METHYLPARABEN, PROPYLENE GLYCOL, PROPYLPARABEN, PURIFIED WATER, SODIUM CITRATE AND SUCRALOSE.
Ask A Doctor Section
ASK A DOCTOR SECTION:
aSK A DOCTOR OR PHARMACIST IF YOU ARE TAKINGSEDATIVES OR TRANKILIZERS.
Do Not Use Section
DO NOT USE SECTION:
DO NORT USE TO SEDATE A CHILD OR TO MAKE A CHILD SLEEPY.
Do not use if you are now taking a prescription monoamine oxidase inhibitor(MAOI) (certain drugs for depression, psychiatric or emotional condition, or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI ask a doctor or pharmacist before taking this product.
Keep Out Of Reach Of Children Section.
Keep out of reach of children section.
In case of a overdose, get medical help or contact a Poison Control Center right away.
Pregnancy Or Breast Feeding Section
Pregnancy or Breast Feeding Section:
If pregnancy or breaft-feeding, ask a heath professional before use
Purpose Section
PURPOSE SECTION:
ANTIHISTAMINE, COUGH SUPRESSANT AND NASAL DESCONGESTANT.
Question Section
QUESTION SECTION
QUESTION OR COMMENTS:
PHONE 1-787-548-0016. LABOR HOUR 8:00 AM TO 5:00 PM.
Stop Use Section.
STOP USE SECTION.
STOP USE OR ASK A DOCTOR IF:
YOU GET NERVOUS, DIZZY, OR SLEEPLESS
COUGH LAST MORE THAN 7 DAYS, COMES BACK, OR IS ACCOMPANIED BY FEVER, RASH OR PERSISTENT HEADACHES.
Warnings Section
WARNINGS SECTION
DO NORT USE TO SEDATE A CHILD OR TO MAKE A CHILD SLEEPY.
Do not use if you are now taking a prescription monoamine oxidase inhibitor(MAOI) (certain drugs for depression, psychiatric or emotional condition, or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI ask a doctor or pharmacist before taking this product.
Indication And Usage
INDICATION AND USAGE
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 occuring with comon cold.
Temporarily restore freer breathing through the nose.
Adults and children 12 or older--------2 tsp (10 ml) every 4 hours
Children age 6 - 12 ----- 1 tsp (5ml) every 4 hours
Children younger tahn 6. ------ Ask a doctor
Dosage And Administration
Dosage and administration:
Adults and children 12 or older--------2 tsp (10 ml) every 4 hours
Children age 6 - 12 ----- 1 tsp (5ml) every 4 hours
Children younger tahn 6. ------ Ask a doctor
Package Label-Principal Display Panel
Package Label-Principal Display Panel
NDC 76117 - 001 - 16
RYCONTUSS
LIQUID
CHERRY FLAVOR
ANTITISSIVE NASAL
DECONGESTANT AND
ANTIHISTAMINE
16 FL OZ (1 PINT) (473 ML)
* Please review the disclaimer below.
