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PediaCare Multi Symptom Cold

Dosage form: liquid
Ingredients: ACETAMINOPHEN 160mg in 5mL, CHLORPHENIRAMINE MALEATE 1mg in 5mL, DEXTROMETHORPHAN HYDROBROMIDE 5mg in 5mL, PHENYLEPHRINE HYDROCHLORIDE 2.5mg in 5mL
Labeler: Strides Pharma Inc
NDC Code: 59556-851

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.

PEDIACARE CHILDRENS MULTI SYMPTOM COLD - acetaminophen,
chlorpheniramine maleate, dextromethorphan hydrobromide and phenylephrine hydrochloride liquid

Drug Facts

Active ingredients

(in each 5 mL)

Acetaminophen 160 mg

Chlorpheniramine maleate 1 mg

Dextromethorphan HBr 5 mg

Phenylephrine HCl 2.5 mg

Purposes

Acetaminophen 160 mg………….. Fever reducer/ pain reliever

Chlorpheniramine maleate 1 mg….Antihistamine

Dextromethorphan HBr 5 mg……Cough Suppressant

Phenylephrine HCl 2.5 mg……… Nasal decongestant

Uses
  • temporarily relieves these common cold and flu symptoms:
  • minor aches and pains
  • headache
  • sore throat
  • stuffy nose
  • cough
  • 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

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

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 a 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.
  • if the child is allergic to any of the ingredients in this product

Ask a doctor before use if the child has

  • glaucoma
  • thyroid disease
  • diabetes
  • high blood pressure
  • heart disease
  • a breathing problem such as chronic bronchitis
  • persistent or chronic cough such as occurs with asthma
  • cough that occurs with excessive phlegm (mucus)
  • liver disease

Ask a doctor or pharmacist before use if child is

  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

When using this product

  • do not exceed recommended dosage (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

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

Keep out of reach of children

Overdose Warning: Taking more than the recommended dose (overdose) could cause serious health problems, including liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions
  •   do not take more than directed (see overdose warning)
  •   do not use in infants
  •   this product does not contain directions or complete warnings for adult use
  •   shake well before using
  •   use only the provided dosing cup
  •   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
  •   mL = millilitre
Weight (lbs)
Age (yrs)
Dose (mL)
under 36
under 4
do not use
36 - 47
4 to under 6
do not use unless directed by doctor
48 - 95
6 - 11
10 mL

Other information
  • dosage cup provided
  • store at 20°-25°C (68°-77°F)
  • Tamper Evident: Do not use if printed safety seal on the bottle is broken or missing

Inactive ingredients

carboxymethylcellulose sodium, citric acid (anhydrous), FD&C blue no.1, FD&C red no.40, flavors, glycerin, microcrystalline cellulose, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

Questions? 1-888-474-3099

PediaCare.com

PRINCIPAL DISPLAY PANEL

PediaCare Multi Symptom Cold

Plus Acetaminophen

Grape Flavor

4 FL OZ (118 mL)

Carton

Container Label - Top

Container Label - Base

Container Label - Back

PEDIACARE MULTI SYMPTOM COLD 
acetaminophen,chlorpheniramine maleate,dextromethorphan hbr,phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59556-851
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN160 mg  in 5 mL
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE1 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
CARBOXYMETHYLCELLULOSE SODIUM 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GLYCERIN 
MICROCRYSTALLINE CELLULOSE 
SODIUM BENZOATE 
SORBITOL 
SUCRALOSE 
WATER 
XANTHAN GUM 
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPE (Grape Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:59556-851-58118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/09/2010
Labeler - Strides Pharma Inc (078868278)
Establishment
NameAddressID/FEIOperations
Fareva Richmond, Inc.969523245MANUFACTURE(59556-851), ANALYSIS(59556-851), LABEL(59556-851), PACK(59556-851)

 
Strides Pharma Inc

Medically reviewed on Aug 7, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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