Label: DEXCHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL tablet

  • NDC Code(s): 66576-080-01
  • Packager: Syntho Pharmaceuticals Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated November 3, 2022

If you are a consumer or patient please visit this version.

  • Active Ingredients (in each tablet)

    1. Dexchlorpheniramine Maleate - 2 mg
    2. Phenylephrine HCl - 10 mg
  • Inactive ingredients

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

  • Purpose

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

  • Warnings

    ■ 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

    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?

    Call 1-800-664-1490

  • KEEP OUT OF REACH OF CHILDREN

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

    Rymed Tablets

  • INGREDIENTS AND APPEARANCE
    DEXCHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL 
    dexchlorpheniramine maleate, phenylephrine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66576-080
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE10 mg
    DEXCHLORPHENIRAMINE MALEATE (UNII: B10YD955QW) (DEXCHLORPHENIRAMINE - UNII:3Q9Q0B929N) DEXCHLORPHENIRAMINE MALEATE2 mg
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    WATER (UNII: 059QF0KO0R)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeOVALSize12mm
    FlavorImprint Code ED;DM
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66576-080-01100 in 1 BOTTLE; Type 0: Not a Combination Product11/02/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34111/02/2022
    Labeler - Syntho Pharmaceuticals Inc. (088797407)
    Registrant - Syntho Pharmaceuticals Inc. (088797407)
    Establishment
    NameAddressID/FEIBusiness Operations
    Syntho Pharmaceuticals Inc.088797407manufacture(66576-080)