Label: DAYTIME COUGH AND COLD- dextromethorphan hydrobromide and phenylephrine hydrochloride liquid

  • 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 September 28, 2011

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients
    (in each 5 mL, 1 teaspoonful)    		Purposes
    Dextromethorphan HBr, USP 5 mgCough suppressant
    Phenylephrine HCl, USP 1.25 mgNasal 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 agedo not use
    Children 4 to under 6 years of age1-1½ tsp.
    (5-7.5 mL)
    Children 6 to under 12 years of age1½-3 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:45014-152
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide5 mg  in 5 mL
    Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride1.25 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    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    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45014-152-04118 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34110/26/2009
    Labeler - Accudial Pharmaceutical, Inc. (831999201)
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