ALLERGY AND STUFFY NOSE (CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [ACCUDIAL PHARMACEUTICAL, INC.]

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  • ALLERGY AND STUFFY NOSE (CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [ACCUDIAL PHARMACEUTICAL, INC.]

ALLERGY AND STUFFY NOSE (CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [ACCUDIAL PHARMACEUTICAL, INC.]
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NDC 45014-141-04
Set ID 96ebdeec-9f97-44a6-adce-b2e100d3168e
Category HUMAN OTC DRUG LABEL
Packager Accudial Pharmaceutical, Inc.
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
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  • SPL UNCLASSIFIED SECTION

    ALLERGY & STUFFY NOSE

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients
    (in each 5 mL, 1 teaspoonful)    		Purposes
    Chlorpheniramine maleate 1 mgAntihistamine
    Phenylephrine HCl 2.5 mgNasal decongestant
  • Uses

    • temporarily relieves
      • itchy, watery eyes
      • runny nose
      • itchy nose or throat
      • sneezing
      • nasal and sinus congestion as may occur with a cold
  • Warnings

    Do not use

    • in a child under 4 years of age
    • in a child who is 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 the child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
    • for the purpose of making your child sleepy

    Ask a doctor before use if the child has

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • glaucoma
    • a breathing problem such as asthma or chronic bronchitis

    Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers

    When using this product

    • do not exceed recommended dosage
    • marked drowsiness may occur
    • sedatives and tranquilizers may increase drowsiness
    • 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 occur with a fever. These could be signs of a serious condition.

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

  • Directions

    • may be given every 4 hours. Do not give more than 6 doses in 24 hours unless directed by a doctor.
    • to find right dose, use rotating bottle label to dose by weight; otherwise, use chart below to dose by age.
    • specifically designed for use with enclosed dosing spoon. Use only enclosed dosing spoon to dose this product. Do not use any other dosing device.
    AgeDose
    children under 4 years of agedo not use
    children 4 to under 6 years of agedo not use unless directed by a doctor
    children 6 to under 12 years of age1-2 tsp. (5-10 mL)
  • Other information

    • each teaspoonful contains: sodium 3 mg
    • store at controlled room temperature 20°-25°C (68°-77°F)
  • Inactive ingredients

    artificial flavor, benzoic acid, citric acid, disodium EDTA, FD&C yellow #6, propylene glycol, purified water, sodium citrate, sodium saccharin, sorbitol.

  • Questions?

    877-434-2036

  • PRINCIPAL DISPLAY PANEL - 118 mL Carton

    CHILDREN'S
    ACCUDIAL

    ROTATING DOSING LABEL

    Allergy
    & Stuffy Nose

    ACCURATE DOSING
    BY WEIGHT

    Chlorpheniramine maleate
    (Antihistamine)

    Phenylephrine HCl
    (Nasal Decongestant)

    Itchy, Watery Eyes
    Runny Nose
    Stuffy Nose
    Sneezing

    For Ages 6 to under 12

    Compares to
    Children's Triaminic®
    Cold & Allergy.

    ORANGE
    FLAVOR

    4 FL. OZ.
    (118 mL)
    NDC 45014-141-04

    Principal Display Panel - 118 mL Carton
  • INGREDIENTS AND APPEARANCE
    ALLERGY AND STUFFY NOSE 
    chlorpheniramine maleate and phenylephrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45014-141
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Chlorpheniramine Maleate (UNII: V1Q0O9OJ9Z) (Chlorpheniramine - UNII:3U6IO1965U) Chlorpheniramine Maleate1 mg  in 5 mL
    Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride2.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    Orange (UNII: 5EVU04N5QU)  
    Benzoic Acid (UNII: 8SKN0B0MIM)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Water (UNII: 059QF0KO0R)  
    Sodium Citrate (UNII: 1Q73Q2JULR)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    Sorbitol (UNII: 506T60A25R)  
    Product Characteristics
    ColorORANGEScore    
    ShapeSize
    FlavorORANGEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45014-141-04118 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34111/11/2009
    Labeler - Accudial Pharmaceutical, Inc. (831999201)
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