Label: CHILDRENS NIGHT TIME COUGH AND COLD RELIEF- diphenhydramine hydrochloride, phenylephrine hydrochloride liquid

  • Category: HUMAN OTC DRUG LABEL

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 April 1, 2013

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  • Active ingredients

    Drug Facts

    Active ingredients

    (in each 5 mL tsp)

    Diphenhydramine HCL,USP 6.25 mg
    Phenylephrine HCL, USP 2.5 mg

  • Purpose

    Antihistamine / Cough Suppressant
    Nasal Decongestant

  • Keep out of reach of children

    Keep out of reach of children.

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

  • Uses

    • temporarily controls cough due to minor throat and bronchial irritation and relieves nasal congestion as may occur with a cold
    • temporarily relieves the following symptoms due to hay fever or other upper respiratory allergies:
    • sneezing
    • runny nose
    • itchy, watery eyes
    • itchy nose or throat                  
  • Warnings

    Do not use

    • with any other product containing diphenhydramine, even one used on the skin
    • to make a child sleepy
    • If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for two weeks after stopping the MAOI drug. If you do not know if your child’s prescription drug contains an MAOI, ask a doctor or a pharmacist before taking this product.
  • Ask a doctor before use if the child has

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • glaucoma
    • a breathing problem such as chronic bronchitis
    • persistent or chronic cough such as occurs with asthma
    • cough that occurs with too much phlegm (mucus)
  • Ask a doctor or pharmacist before use if the child is

    • taking sedatives or tranquilizers.
  • When using this product

    • do not use more than directed
    • excitability may occur, especially in children
    • marked drowsiness may occur
    • sedatives and tranquilizers may increase drowsiness
  • Stop use and ask a doctor if

    • nervousness, dizziness or sleeplessness occus
    • symptoms do not get better within 7 days or occur with fever
    • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache.


    These could be signs of a serious condition.

  • Directions

    • do not use more than directed
    • do not take more than 6 doses in any 24-hour period
    • use dosage cup or teaspoon
    AptaPharmaPV ChildrensNightTimeCC2 Label
  • Other information

    • each teaspoonful contains: sodium 3 mg
    • store between 20-25 ° C (68-77° F)
    • do not refrigerate
    • dosage cup provided
    • Keep carton for full directions for use
  • Inactive ingredients

    acesulfame potassium, citric acid anhydrous, edeate disodium, FD and C blue #1, FD and C red # 40, flavors, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate

  • Questions?

    Call weekdays from 9:30 AM to 4:30 PM EST at

     1-877-798-5944

  • Product Label

    NDC 68016-143-00

    *COMPARE TO THE ACTIVE INGREDIENTS IN DELSYM® CHILDREN'S NIGHT TIME COUGH and COLD

    Premier Value®
    Children's Night Time

    COUGH and COLD RELIEF

    Diphenhydramine HCL..........Antihistamine / Cough Suppressant
    Phenylephrine HCL ............ Nasal Decongestant

    Sneezing
    Runny Nose
    Cough
    Stuffy Nose


    Grape Flavored Liquid
    4 FL OZ (118mL)

    INDEPENDENTLY TESTED SATISFACTION GUARANTEED PV
    DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

    *This product is not manufactured or distributed by Reckitt Benckiser Inc. distributor of Delsym® Children's Night Time Cough and Cold
    If for Any reason you are not satisfied with this product, lease return it to the store where purchased for a full refund.

    DISTRIBUTED BY
    CHAIN DRUG CONSORTIUM
    3301 NW BOCA RATON BLVD
    SUITE 101, BOCA RATON, FL 33431
    BX-008

    AptaPharmaPV ChildrensNightTimeCC Label

  • INGREDIENTS AND APPEARANCE
    CHILDRENS NIGHT TIME  COUGH AND COLD RELIEF
    diphenhydramine hydrochloride, phenylephrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-143
    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
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MALTITOL (UNII: D65DG142WK)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPE (Grape Flavored) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-143-00118 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/01/2012
    Labeler - Chain Drug Consortium, LLC (101668460)
    Registrant - AptaPharma Inc. (790523323)
    Establishment
    NameAddressID/FEIBusiness Operations
    AptaPharma Inc.790523323manufacture(68016-143)