Label: PEDIACARE CHILDRENS ALLERGY AND COLD- phenylephrine hydrochloride and diphenhydramine hydrochloride liquid 

  • Label RSS
  • NDC Code(s): 52183-389-04
  • Packager: Blacksmith Brands, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 08/10

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

  • SPL UNCLASSIFIED SECTION

    PediaCare Children’s Allergy & Cold

    Drug Facts

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  • Active ingredients (in each 5 mL)*

    Diphenhydramine HCl 12.5 mg

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  • Purposes

    Antihistamine/cough suppressant

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  • Active ingredients (in each 5 mL)*

    Phenylephrine HCl 5 mg

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  • Purposes

    Nasal decongestant

    *5 mL = one teaspoon

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  • Uses

    • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • sneezing
    • itchy, watery eyes
    • nasal congestion
    • itching of the nose or throat
    • temporarily relieves these symptoms due to the common cold:
    • runny nose
    • sneezing
    • nasal congestion
    • cough
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  • Warnings

    Do not use

    • to make a child sleepy
    • with any other product containing diphenhydramine, even one used on skin
    • 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 your 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
    • persistent or chronic cough such as occurs with asthma
    • cough accompanied by excessive phlegm (mucus)
    • a breathing problem such as chronic bronchitis
    • glaucoma

    Ask a doctor or pharmacist before use

    if the child is taking sedatives or tranquilizers

    When using this product

    • do not exceed recommended dose
    • 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 occur
    • symptoms do not improve within 7 days or occur with a fever
    • cough gets worse or lasts for more than 7 days
    • cough tends to come back or occurs with fever, rash or headache that lasts

    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. (1-800-222-1222)

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  • Directions

    • find right dose on chart below
    • use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
    • take every 4 hours
    • do not take more than 6 doses in 24 hours
    Age (yr) Dose (tsp)
    Under 4 years Do not use
    4 to 5 years Do not use unless directed by a doctor
    6 to 11 years 1 teaspoonful

    Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

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  • Other information

    • each teaspoon contains: sodium 10 mg
    • store between 20-25°C (68-77°F). Protect from light.
    • do not use if bottle wrap, or foil inner seal imprinted “Safety Seal®” is broken or missing
    • see bottom panel for lot number and expiration date

    Store in outer carton until contents are used.

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  • Inactive ingredients

    anhydrous citric acid, carboxymethylcellulose sodium, edetate disodium, FD&C blue #1, FD&C red #40, flavors, glycerin, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

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  • Questions or comments?

    call 1-888-474-3099

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  • PRINCIPAL DISPLAY PANEL

    See New Warnings & Directions
    PediaCare
    Children’s

    Allergy & Cold

    Phenylephrine HCI, Diphenhydramine HCI
    4 FL OZ (118
    mL)

    PRINCIPAL DISPLAY PANEL
PediaCare Children’s Allergy & Cold
Phenylephrine HCI, Diphenhydramine HCI
4 FL OZ (118 mL)

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  • INGREDIENTS AND APPEARANCE
    PEDIACARE CHILDRENS ALLERGY AND COLD 
    diphenhydramine hydrochloride and phenylephrine hydrochloride liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:52183-389
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 5 mg  in 5 mL
    DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    ANHYDROUS CITRIC ACID  
    CARBOXYMETHYLCELLULOSE SODIUM  
    EDETATE DISODIUM  
    FD&C BLUE NO. 1  
    FD&C RED NO. 40  
    GLYCERIN  
    WATER  
    SODIUM BENZOATE  
    SODIUM CITRATE  
    SORBITOL  
    SUCRALOSE  
    Product Characteristics
    Color PURPLE Score     
    Shape Size
    Flavor GRAPE Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52183-389-04 1 in 1 CARTON
    1 118 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 10/29/2009
    Labeler - Blacksmith Brands, Inc. (021411299)
    Establishment
    Name Address ID/FEI Business Operations
    Trillium Healthcare Products, Inc. 255426306 MANUFACTURE
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