RYMED TABLETS

Manufacturer
Syntho Pharmaceuticals Inc.
Effective date
2022-11-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:51:28

Label at a glance#

ProductDexchlorpheniramine Maleate, Phenylephrine HCl
Active ingredientPHENYLEPHRINE HYDROCHLORIDE, DEXCHLORPHENIRAMINE MALEATE
Label structure8 sections

Indications and uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: ■ runny nose ■ sneezing ■ itching of the nose or throat ■ itchy, watery eyes ■ nasal congestion ■ reduces swelling of nasal passages

Dosage and administration

Do not exceed recommended dosage. Adults and children 12 years of age and over: 1 tablet every 4 hours, not to exceed 6 tablets in 24 hours, or as directed by a doctor Children 6 to under 12 years of age: 1/2 tablet every 4 hours, not to exceed 3 tablets in 24 hours, or as directed by a doctor Children under 6 years of age: Consult a doctor.

Label contents#

Full prescribing information#

Active Ingredients (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

  1. Dexchlorpheniramine Maleate - 2 mg
  2. Phenylephrine HCl - 10 mg

Inactive ingredients

INACTIVE INGREDIENT SECTION

Lactose Monohydrate, Microcrystalline Cellulose, Magnesium Stearate, Purified Water, PEG, HPMC

Purpose

OTC - PURPOSE SECTION

  1. Dexchlorpheniramine Maleate 2 mg -  Antihistamine
  2. Phenylephrine HCl 10 mg - Nasal Decongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
■ runny nose
■ sneezing
■ itching of the nose or throat
■ itchy, watery eyes
■ nasal congestion
■ reduces swelling of nasal passages

Warnings

WARNINGS SECTION

■ Do not exceed recommended dosage.

Do not use this product
■ 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 your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have
■ a breathing problem such as emphysema or chronic bronchitis
■ glaucoma 
■ heart disease
■ high blood pressure 
■ thyroid disease
■ diabetes mellilus
■ difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product
■ excitability may occur, especially in children
■ may cause drowsiness
■ alcohol, sedatives and tranquilizers may increase the drowsiness effect
■ avoid alcoholic beverages
■ use caution when driving a motor vehicle or operating machinery

Stop use and ask a doctor if
■ nervousness, dizziness, or sleeplessness occur
■ symptoms do not improve within 7 days or are accompanied by a fever
■ new symptoms occur

If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Do not exceed recommended dosage.

Adults and children 12 years of age and over:1 tablet every 4 hours, not to exceed 6 tablets in 24 hours, or as directed by a doctor
Children 6 to under 12 years of age:1/2 tablet every 4 hours, not to exceed 3 tablets in 24 hours, or as directed by a doctor
Children under 6 years of age:Consult a doctor.

Questions or Comments?

OTC - QUESTIONS SECTION

Call 1-800-664-1490

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rymed Tablets - NDC 66576-080-01 - 100's Bottle Label

Rymed TabletsRymed Tablets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2184108dexchlorpheniramine maleate 2 MG / phenylephrine HCl 10 MG Oral TabletPSN1
2184108dexchlorpheniramine maleate 2 MG / phenylephrine hydrochloride 10 MG Oral TabletSCD1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
44893bf2-1be4-4e68-8bc4-bbb0f543085eProduct name120180830

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66576-080-012024-01-30C16284748780-11030e365-44e5-111a-e063-dadaa90a10e2RYMED TABLETS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66576-080-01Dexchlorpheniramine Maleate, Phenylephrine HCl100 in 1 BOTTLETABLET1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66576-080DEXCHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL TABLET [SYNTHO PHARMACEUTICALS INC.]1Legacy NDC, 1 package rows20221110_fe6514a8-353f-4af4-89e7-1e6493f50224.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66576-08066576-080-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

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
ec8e1b86-9fd7-2534-e053-2a95a90a8bb3fe6514a8-353f-4af4-89e7-1e6493f502242022-11-03WarningsExact identifier
spl id: ec8e1b86-9fd7-2534-e053-2a95a90a8bb3
spl set id: fe6514a8-353f-4af4-89e7-1e6493f50224

Reported adverse events (FAERS/openFDA)#

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