Label: NITE TIME COLD AND COUGH- diphenhydramine hydrochloride 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 November 11, 2009

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  • SPL UNCLASSIFIED SECTION

    NITE TIME COLD & COUGH

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients
    (in each 5 mL, 1 teaspoonful)    		Purposes
    Diphenhydramine HCl 6.25 mgAntihistamine/Cough suppressant
    Phenylephrine HCl 2.5 mgNasal decongestant
  • Uses

    • temporarily relieves
    • sneezing
    • itchy nose or throat
    • runny nose
    • itchy, watery eyes due to hay fever
    • 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 6 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.
    • with any other product containing diphenhydramine, even one used on skin
    • 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
    • cough that occurs with too much phlegm (mucus)
    • chronic cough that lasts, or as occurs with asthma
    • a breathing problem such as 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
    • 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 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.
    children under 6 years of agedo not use
    children 6 to under 12 years of age1-2 tsp. (5-10 mL)
  • Other information

    • each teaspoonful contains: sodium 4 mg
    • store at controlled room temperature 20°-25°C (68°-77°F)
  • Inactive ingredients

    artificial flavor, benzoic acid, citric acid, disodium edetate, FD&C blue no. 1, FD&C red no. 40, 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

    Nite Time
    Cold & Cough

    ACCURATE DOSING
    BY WEIGHT

    Diphenhydramine HCl
    (Antihistamine/Cough Suppressant

    Phenylephrine HCl
    (Nasal Decongestant)

    Cough Relief
    Runny, Stuffy Nose
    Itchy Throat

    For Ages 6 to under 12

    Compares to Children's
    Triaminic® Night Time
    Cold & Cough.

    GRAPE
    FLAVOR

    4 FL. OZ.
    (118 mL)
    NDC 45014-154-04

    Principal Display Panel - 118 mL Carton
  • INGREDIENTS AND APPEARANCE
    NITE TIME COLD AND COUGH 
    diphenhydramine hydrochloride and phenylephrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45014-154
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M) Diphenhydramine Hydrochloride6.25 mg  in 5 mL
    Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride2.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    Grape (UNII: 6X543N684K)  
    Benzoic Acid (UNII: 8SKN0B0MIM)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    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
    ColorPURPLEScore    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45014-154-04118 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34111/25/2009
    Labeler - Accudial Pharmaceutical, Inc. (831999201)
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