PEDIACARE CHILDRENS PLUS COUGH AND RUNNY NOSE- chloropheniramine maleate and dextromethorphan hydrobromide and acetaminophen liquid 
Blacksmith Brands, 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 Cough and Runny Nose

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

Uses

  • temporarily relieves the following cold/flu symptoms:
  • minor aches and pains
  • cough
  • headache
  • sore throat
  • sneezing and runny 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 non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if 

your child has

  • glaucoma
  • a breathing problem such as chronic bronchitis
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with asthma
  • 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
  • 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)
  • do not use in infants
  • 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

acesulfame potassium, carboxymethylcellulose sodium, cellulose, citric acid, flavors, glycerin, high fructose corn syrup, purified water, red 33, red 40, sodium benzoate, sorbitol, xanthan gum

Questions or comments?

call 1-888-474-3099

Distributed by:
Blacksmith Brands Inc.
200 White Plains Road
Tarrytown, NY 10591 USA
© 2010

PRINCIPAL DISPLAY PANEL

PediaCare®
Children’s
Fever Reducer
Pain Reliever Plus Cough & Runny Nose
Luden’s® Cherry Taste!
4 FL OZ (118 mL)

PRINCIPAL DISPLAY PANEL PediaCare Childrens Fever Reducer Pain Reliever Plus Cough & Runny Nose Cherry Taste
PEDIACARE CHILDRENS PLUS COUGH AND RUNNY NOSE 
chloropheniramine maleate and dextromethorphan hydrobromide and acetaminophen liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52183-375
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
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
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
WATER (UNII: 059QF0KO0R)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52183-375-041 in 1 BOX07/09/201006/07/2017
1113 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/09/201006/07/2017
Labeler - Blacksmith Brands, Inc. (159655021)

Revised: 9/2017
 
Blacksmith Brands, Inc.