Rycontuss

Rycontuss
SPL v1
SPL
SPL Set ID 41afb883-1158-9764-e063-6294a90a1712
Route
ORAL
Published
Effective Date 2011-05-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenylephrine (5 mg) Chlorpheniramine (2 mg) Dextromethorphan (10 mg)
Inactive Ingredients
Citric Acid Fd&c Red No. 40 Methylparaben Propylparaben Sodium Citrate Propylene Glycol D&c Red No. 33 Water Sucralose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2011-05-31

Description

ACTIVE INGREDIENT SECTION CHLORPHENIRAMINE MALEATE 2MG DEXTROMETHORPHAN HYDROBROMIDE 10MG PHENYLEPHRINE HYDROCHLORIDE 5MG

Purpose

PURPOSE SECTION: ANTIHISTAMINE, COUGH SUPRESSANT AND NASAL DESCONGESTANT.

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


Medication Information

Purpose

PURPOSE SECTION: ANTIHISTAMINE, COUGH SUPRESSANT AND NASAL DESCONGESTANT.

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

Description

ACTIVE INGREDIENT SECTION CHLORPHENIRAMINE MALEATE 2MG DEXTROMETHORPHAN HYDROBROMIDE 10MG PHENYLEPHRINE HYDROCHLORIDE 5MG

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.

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.

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.

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.

Ask A Doctor Section

ASK A DOCTOR SECTION:

aSK A DOCTOR OR PHARMACIST IF YOU ARE TAKINGSEDATIVES OR TRANKILIZERS.

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

Active Ingredient Section

ACTIVE INGREDIENT SECTION

CHLORPHENIRAMINE MALEATE 2MG

DEXTROMETHORPHAN HYDROBROMIDE 10MG

PHENYLEPHRINE HYDROCHLORIDE 5MG

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.

Pregnancy Or Breast Feeding Section

Pregnancy or Breast Feeding Section:

If pregnancy or breaft-feeding, ask a heath professional before use

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)

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.


Structured Label Content

Purpose Section (PURPOSE SECTION)

PURPOSE SECTION:

ANTIHISTAMINE, COUGH SUPRESSANT AND NASAL DESCONGESTANT.

Question Section (QUESTION SECTION)

QUESTION SECTION

QUESTION OR COMMENTS:

PHONE 1-787-548-0016. LABOR HOUR 8:00 AM TO 5:00 PM.

Warnings Section (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.

Stop Use Section. (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.

Do Not Use Section (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.

Ask A Doctor Section (ASK A DOCTOR SECTION)

ASK A DOCTOR SECTION:

aSK A DOCTOR OR PHARMACIST IF YOU ARE TAKINGSEDATIVES OR TRANKILIZERS.

Indication and Usage (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

Active Ingredient Section (ACTIVE INGREDIENT SECTION)

ACTIVE INGREDIENT SECTION

CHLORPHENIRAMINE MALEATE 2MG

DEXTROMETHORPHAN HYDROBROMIDE 10MG

PHENYLEPHRINE HYDROCHLORIDE 5MG

Dosage and Administration (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

Inactive Ingredient Section (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.

Pregnancy Or Breast Feeding Section (Pregnancy or breast feeding section)

Pregnancy or Breast Feeding Section:

If pregnancy or breaft-feeding, ask a heath professional before use

Package Label Principal Display Panel (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)

Keep Out of Reach of Children Section. (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.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)