FDA.reportPublic FDA data

Rycontuss

Manufacturer
Dextrum Laboratories, Inc
Effective date
2025-10-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:40:04

Label at a glance#

ProductRycontuss
Active ingredientPHENYLEPHRINE HYDROCHLORIDE, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE
Label structure13 sections

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

Label contents#

Full prescribing information#

ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENT SECTION

CHLORPHENIRAMINE MALEATE 2MG

DEXTROMETHORPHAN HYDROBROMIDE 10MG

PHENYLEPHRINE HYDROCHLORIDE 5MG

active ingredientactive ingredient

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.

inactiveinactive

ASK A DOCTOR SECTION

OTC - ASK DOCTOR SECTION

ASK A DOCTOR SECTION:

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

ASK A DOCTORASK A DOCTOR

DO NOT USE SECTION

OTC - 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.

do not usedo not use

Keep out of reach of children section.

OTC - 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.

Keep outKeep out

Pregnancy or breast feeding section

OTC - PREGNANCY OR BREAST FEEDING SECTION

Pregnancy or Breast Feeding Section:

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

pregnantpregnant

PURPOSE SECTION

OTC - PURPOSE SECTION

PURPOSE SECTION:

ANTIHISTAMINE, COUGH SUPRESSANT AND NASAL DESCONGESTANT.

purposepurpose

QUESTION SECTION

OTC - QUESTIONS SECTION

QUESTION SECTION

QUESTION OR COMMENTS:

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

questionquestion

STOP USE SECTION.

OTC - 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.

Stop useStop use

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.

WarningWarning

INDICATION AND USAGE

INDICATIONS & USAGE SECTION

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

indication an userindication an user

Dosage and administration

DOSAGE & ADMINISTRATION SECTION

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

dosagedosage

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)

principal panelprincipal panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1363752chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 5 mL Oral SolutionPSN1
1363752chlorpheniramine maleate 0.4 MG/ML / dextromethorphan hydrobromide 2 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral SolutionSCD1
1363752chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 5 ML Oral SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHLORPHENIRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65852-021-16Rycontuss473 mL in 1 BOTTLE, PLASTICLIQUID4731

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65852-02165852-021-16

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
CITRIC ACID2968PHW8QPIACT
FD&C RED NO. 40WZB9127XOAIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
SODIUM CITRATE1Q73Q2JULRIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CHLORPHENIRAMINE MALEATEV1Q0O9OJ9ZACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
D&C RED NO. 339DBA0SBB0LIACT
WATER059QF0KO0RIACT
SUCRALOSE96K6UQ3ZD4IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RycontussCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEDextrum Laboratories, Inc41afb883-1158-9764-e063-6294a90a17122025-10-21WarningsExact identifier
ndc (package): 65852-021-16
ndc (product): 65852-021
ndc11 (package): 65852002116
spl id: 41afb883-1159-9764-e063-6294a90a1712
spl set id: 41afb883-1158-9764-e063-6294a90a1712

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.