ED A-HIST (CHLORPHENIRAMINE/PHENYLEPHRINE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]

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ED A-HIST (CHLORPHENIRAMINE/PHENYLEPHRINE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]
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NDC 0485-0155-16
Set ID bf5c4a23-9581-4b84-a75b-e17e1d768970
Category HUMAN OTC DRUG LABEL
Packager Edwards Pharmaceuticals, Inc.
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
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  • Drug Facts

    Active ingredients (in each 5 mL teaspoonful)

    Chlorpheniramine Maleate 4mg

    Phenylephrine Hydrochloride 10 mg

    Alcohol.............................................5%

  • Purpose

    Antihistamine.........................Nasal Decongestant

  • Uses

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

  • Warnings: Do not exceed recommended dosage.


    Do not use this product

    • if you are now taking prescription monaimine 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 know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

    Do not take this product, unless directed by a doctor before use if you have

    • A breathing problem such as emphysema or chronic bronchitis
    • Glaucoma, heart disease, diabetes, high blood pressure or thyroid disease
    • 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 the product

    • May cause drowsiness
    • Avoid alcoholic beverages
    • Alcohol, sedatives, and tranquilizers may increase drowsiness
    • Be careful when driving a motor vehicle or operating machinery
    • Excitability may occur, especially in children.

    Stop use and ask a doctor if

    • Nervousness, dizziness, or sleeplessness occurs
    • Symptoms do not improve within 7 days or are accompanied by a fever.

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    Do not exceed recommended dosage.

    Adults and children 12 years of age and over:1 teaspoonful (5 mL) every 4 hours, not to exceed 6 teaspoonfuls in a 24 hour period
    Children 6 to under 12 years of age:
    		1/2 teaspoonful (5 mL) every 4 hours, not to exceed 6 teaspoonfuls in a 24 hour period
    Children under 6 years of age:Consult a Doctor

    A special measuring device should be used to give an accurate dose of this product to children under 12 years of age. Giving a higher dose than recommended by a doctor could result in serious side effects for your child.

  • Other information:

    Store at 59° - 86°F (15° - 30°C)

  • Inactive ingredients:

    FD and C Blue #1, Grape Flavor, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol, and FD and C Red #40.

  • Questions or comments?

    Call 1-800-543-9560

    Iss. 12/10

  • Product Packaging

    The packaging below represents the labeling currently used:

    Principal display panel and side panel for 473 mL label:

    NDC 0485-0155-16
    ED A-HIST LIQUID
    ANTIHISTAMINE / DECONGESTANT
    Each 5 mL (one teaspoonful) for oral administration contains:
    Chlorpheniramine Maleate..............................4 mg
    Phenyleprhing Hydrochloride.........................10 mg
    Alcohol USP.....................................................5%

    GLUTEN FREE / SUGAR FREE

    DO NOT USE IF FOIL SEAL UNDER CAP IS BROKEN OR MISSING

    Manufactured for:
    EDWARDS Pharmaceuticals, Inc.
    Ripley, MS 38663

    Net Contents: 1 pint (473 mL)

    Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.

    dispense in a tight, light-resistant container with a child-resistant closure.

    This bottle is not to be dispensed to consumer.
    Manufactured for: Edwards Pharmaceuticals, Inc., Ripley, MS 38663

    Iss. 12/10

    ED A-HIST Liquid Packaging



    ED A-HIST Liquid Packaging








  • INGREDIENTS AND APPEARANCE
    ED A-HIST 
    chlorpheniramine/phenylephrine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0485-0155
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE4 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALCOHOL (UNII: 3K9958V90M)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0485-0155-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/11/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/11/2011
    Labeler - Edwards Pharmaceuticals, Inc. (195118880)
    Establishment
    NameAddressID/FEIBusiness Operations
    TG United830980947manufacture(0485-0155)
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