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Daytime Cough And Cold (Accudial Pharmaceutical, Inc.)

Available Formats

Dosage Form Package Information Links
LIQUID 118 mL in 1 BOTTLE (45014-152-04) Label Information

Complete Daytime Cough And Cold Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • ACTIVE INGREDIENT

    Active ingredients
    (in each 5 mL, 1 teaspoonful)
    Purposes
    Dextromethorphan HBr, USP 5 mg Cough suppressant
    Phenylephrine HCl, USP 1.25 mg Nasal decongestant

  • Uses

    • temporarily relieves
      • nasal and sinus congestion
      • cough due to minor throat and bronchial irritation 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.

    Ask a doctor before use if the child has

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • cough that occurs with too much phlegm (mucus)
    • chronic cough that lasts, or as occurs with asthma

    When using this product
    • do not exceed recommended dosage

    Stop use and ask a doctor if
    • nervousness, dizziness, or sleeplessness occurs
    • symptoms do not improve within 7 days or occur with a fever
    • cough persists for more than 7 days, comes back, or occurs with a fever, rash, or persistent headache. 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 6 hours. Do not give more than 4 doses in 24 hours unless directed by a doctor.
    Children under 4 years of age do not use
    Children 4 to under 6 years of age 1-1½ tsp.
    (5-7.5 mL)
    Children 6 to under 12 years of age 1½-3 tsp.
    (7.5-15 mL)

  • Other information

    • each teaspoon contains: sodium 2 mg
    • store at controlled room temperature 20°-25°C (68°-77°F)

  • Inactive ingredients

    Artificial Flavor, Benzoic Acid, Citric Acid, EDTA Disodium, FD&C Red #40, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol.


  • QUESTIONS

    question image877-434-2036


  • SPL UNCLASSIFIED SECTION

    Manufactured for
    ACCUDIAL
    PHARMACEUTICAL, INC.
    AccurateDose.com
    Palm Beach Gardens, FL 33410

    Distributed by:
    LeSaint Logistics
    Corporate Headquarters
    2570 Northwest Parkway
    Elgin, IL 60124


  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

    CHILDREN'S
    ACCUDIAL

    ROTATING DOSING LABEL

    Daytime
    Cough & Cold

    ACCURATE DOSING
    BY WEIGHT

    Dextromethorphan HBr
    (Cough Suppressant)

    Phenylephrine HCl
    (Nasal Decongestant)

    Cough
    Stuffy Nose

    For Ages 4 to under 12

    Compares to the active
    ingredients in Children's
    Triaminic® Day Time
    Cold & Cough.

    CHERRY
    FLAVOR

    4 FL.OZ.
    (118 mL)

    NDC 45014-152-04

    PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

  • INGREDIENTS AND APPEARANCE
    DAYTIME COUGH AND COLD 
    dextromethorphan hydrobromide and phenylephrine hydrochloride liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:45014-152
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide 5 mg  in 5 mL
    Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride 1.25 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    Cherry (UNII: BUC5I9595W)  
    Benzoic acid (UNII: 8SKN0B0MIM)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    FD&C red no. 40 (UNII: WZB9127XOA)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Water (UNII: 059QF0KO0R)  
    Sodium Citrate (UNII: 1Q73Q2JULR)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    Sorbitol (UNII: 506T60A25R)  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor CHERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:45014-152-04 118 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 10/26/2009
    Labeler - Accudial Pharmaceutical, Inc. (831999201)