Label: CHILDRENS NIGHTTIME COLD AND COUGH- diphenhydramine hcl, phenylephrine hcl 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 1, 2018

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each 5 mL)
    Diphenhydramine HCI, USP              6.25 mg
    Phenylephrine HCI, USP                    2.5 mg

  • PURPOSE

    Purpose
    Diphenhydramine HCI, USP                 Antihistamine/Cough suppressant
    Phenylephrine HCI, USP                      Nasal decongestant

  • INDICATIONS & USAGE

    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

    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 2 weeks after stopping
      the MAOI drug. If you do not know if your prescription drug contains
      an MAOI, ask a doctor or pharmacist before taking this product.

  • ASK DOCTOR

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

  • ASK DOCTOR/PHARMACIST

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

  • WHEN USING

    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

    Stop use and ask a doctor if
    • nervousness, dizziness or sleeplessness occur
    • 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.

  • 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.

  • DOSAGE & ADMINISTRATION

    Directions
    do not use more than directed
    do not take more than 6 doses in any 24-hour period
    mL=milliliter

    Age                                                          Dose
     Children 6 to under 12 years of age 10 mL every 4 hours
     Children 4 to under 6 years of age Do not use unless directed by a doctor
     Children under 4 years of age Do not use

  • OTHER SAFETY INFORMATION

    Other information
    • each 10 mL contains: sodium 3 mg
    • store between 20-25°C (68-77°F)
    • do not refrigerate
    • dosing cup provided

  • INACTIVE INGREDIENT

    Inactive ingredients
    anhydrous citric acid, flavor, purified water, sodium benzoate, sucrose

  • QUESTIONS

    Ouestions? Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944

  • Principal Display Panel

    CVS
    HealthTM

    Compare to the active
    ingredients in Triaminic®
    Night Time Cold & Cough*

    Children's
    Nighttime
    Cold & Cough

    Free of alcohol, dyes &
    artificial sweeteners

    DIPHENHYDRAMINE HCl
    Antihistamine;
    Cough suppressant

    PHENYLEPHRINE Hel
    Nasal decongestant

    Relieves:
    Cough, stuffy nose
    & itchy throat

    Grape Flavor

    For Ages
    6 to 12 Years

    8 FL OZ (237 mL)

    DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN
    Failure to follow these warnings could result in serious consequences

    *This product is not manufactured or distributed by Novartis
    Consumer Health, Inc., distributor of Triaminic® Night Time
    Cold & Cough.

    Lot:
    Exp:

    LR-115           #194556

    Distributed by: CVS Pharmacy, Inc.
    One CVS Drive, Woonsocket, RI 02895
    © 2018 CVS/pharmacy
    CVS.com® 1-800-SHOP CVS
    V-34874

    √CVS Quality
    Money Back Guarantee

    ↓Product Package↓

    315-26 Label

                                      Children's Nighttime Cold & Cough by CVS Pharmacy, Inc.

    res

  • INGREDIENTS AND APPEARANCE
    CHILDRENS NIGHTTIME COLD AND COUGH 
    diphenhydramine hcl, phenylephrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76281-315
    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) PHENYLEPHRINE2.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76281-315-26237 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/01/2018
    Labeler - AptaPharma Inc. (790523323)
    Registrant - AptaPharma Inc. (790523323)
    Establishment
    NameAddressID/FEIBusiness Operations
    AptaPharma Inc.790523323manufacture(76281-315)