PEDIACARE CHILDRENS PLUS MULTISYMPTOM COLD- acetaminophen, chlorpheniramine maleate, dextromethorphan hbr and phenylephrine hci liquid 
Prestige Brands Holdings, Inc.

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.

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PediaCare Childrens Plus Multisymptom Cold

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 36under 4do not use
36-474-5do not use unless directed by a doctor
48-956-112 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)

PEDIACARE CHILDRENS PLUS MULTISYMPTOM COLD 
acetaminophen, chlorpheniramine maleate, dextromethorphan hbr and phenylephrine hci liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52183-385
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg  in 5 mL
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE1 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52183-385-041 in 1 BOX07/09/201002/28/2018
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/09/201002/28/2018
Labeler - Prestige Brands Holdings, Inc. (159655021)

Revised: 6/2017
 
Prestige Brands Holdings, Inc.