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PediaCare Childrens Plus Multisymptom Cold (Blacksmith Brands, Inc.)

Available Formats

Dosage Form Package Information Links
LIQUID 1 BOTTLE in 1 BOX (52183-385-04) > 113 mL in 1 BOTTLE Label Information

Complete PediaCare Childrens Plus Multisymptom Cold Information

  • SPL UNCLASSIFIED SECTION

    PediaCare Childrens Plus Multisymptom Cold

    Drug Facts


  • Active ingredient

    (in each 5 mL, 1 teaspoon)

    Acetaminophen 160 mg


  • Purpose

    Pain reliever/fever reducer


  • Active ingredient

    (in each 5 mL, 1 teaspoon) 

    Chlorpheniramine maleate 1 mg


  • Purpose

    Antihistamine


  • Active ingredient

    (in each 5 mL, 1 teaspoon) 

    Dextromethorphan HBr 5 mg


  • Purpose

    Cough Suppressant


  • Active ingredient

    (in each 5 mL, 1 teaspoon) 

    Phenylephrine HCI 2.5 mg


  • Purpose

    Nasal decongestant


  • Uses

    • temporarily relieves the following cold/flu symptoms: 
    • minor aches and pains
    • cough headache sore throat
    • sneezing and runny nose stuffy nose
    • temporarily reduces fever

  • Warnings

    Liver warning: This product contains acetaminophen. Sever liver damage may occur if your child takes: 

    • more than 5 doses in 24 hours, which is the maximum daily amount
    • with other drugs containing acetaminophen

    Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.


  • Do not use

    • to make child sleepy
    • 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.
    • with any other drug containing acetaminophen (prescription or non­prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

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

  • Ask a doctor or pharmacist before use if your child is taking

    • sedatives or tranquilizers
    • the blood thinning drug warfarin

    When using this product
    • do not exceed recommended dose (see overdose warning) 
    • may cause excitability, especially in children
    • marked drowsiness may occur
    • sedatives and tranquilizers may increase drowsiness

    Stop use and ask a doctor if
    • new symptoms occur
    • fever gets worse or lasts for more than 3 days 
    • redness or swelling is present
    • pain, nasal congestion or cough gets worse or lasts for more than 5 days 
    • neverousness, dizziness or sleeplessness occur
    • cough comes back or occurs with rash or headache that lasts These could be signs of a serious condition.

    Keep this and all drugs out of the reach of children.

  • Overdose Warning:

    Taking more than the recommended dose (overdose) may cause liver damage. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. Quick medical attention is critical even if you do not notice any signs or symptoms.


  • Directions

    • do not exceed recommended dosage (see overdose warning)
    • this product does not contain directions or complete warnings for adult use. 
    • shake well before using
    • find right dose on chart below. If possible, use weight to dose; otherwise, use age. 
    • if needed, repeat dose every 4 hours while symptoms last
    • do not give more than 5 times in 24 hours
    • tsp = teaspoon, mL = milliliter
    Weight (lb) Age (yr) Dose (tsp or mL)
    under 36 under 4 do not use
    36-47 4-5 do not use unless directed by a doctor
    48-95 6-11 2 tsps or 10 mL

  • Other information

    • dosage cup provided
    • store at room temperature

  • Inactive ingredients

    FD&C blue no. 1, carboxymethylcellulose sodium, cellulose, citric acid, flavors, glycerin, purified water, D&C red no. 33, FD&C red no. 40, sodium benzoate, sorbitol, sucrose, xanthan gum


  • Questions or comments?

    call 1-888-474-3099

    Distributed by: Blacksmith Brands Inc.
    660 White Plains Road Tarrytown, NY 10591 USA

    © 2010


  • PRINCIPAL DISPLAY PANEL

    PediaCare
    Children’s Fever  Reducer
    Pain Reliever Plus Multi­Symptom 
    Luden’s Grape Taste!
    4 FL OZ (118 mL)

    PRINCIPAL DISPLAY PANEL
PediaCare
Children’s Fever  Reducer
Pain Reliever Plus Multi­Symptom 
Luden’s Grape Taste!
4 FL OZ (118 mL)


  • INGREDIENTS AND APPEARANCE
    PEDIACARE CHILDRENS PLUS MULTISYMPTOM COLD 
    acetaminophen, chlorpheniramine maleate, dextromethorphan hbr and phenylephrine hci liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:52183-385
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 160 mg  in 5 mL
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 1 mg  in 5 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 5 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 2.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCROSE (UNII: C151H8M554)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor GRAPE Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52183-385-04 1 in 1 BOX 07/09/2010 02/28/2018
    1 118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 07/09/2010 02/28/2018
    Labeler - Prestige Brands Holdings, Inc. (159655021)