PEDIACARE  PLUS MULTISYMPTOM COLD- acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride liquid 
Moberg Pharma North America LLC

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®
Plus Multisymptom Cold

Drug Facts

Active ingredients (in each 5 mL)Purposes
Acetaminophen 160 mgFever reducer/pain reliever
Chlorpheniramine maleate 1 mgAntihistamine
Dextromethorphan HBr 5 mgCough suppressant
Phenylephrine HCl 2.5 mgNasal 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. Severe 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 non-prescription). 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 = milliliter
Weight (lbs)Age (yrs)Dose (mL)
under 36under 4do not use
36 - 474 to under 6do not use unless directed by a doctor
48 - 956 - 1110 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

Distributed by Moberg Pharma North America LLC
Cedar Knolls, NJ 07927

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Box

Children
6-11 Years

Fast Acting

Pedia
Care
®

100% dedicated
to kids™

Multi
Symptom
Cold

PLUS ACETAMINOPHEN

Fever & Sore Throat
Sneezing & Runny Nose
Cough & Stuffy Nose

Acetaminophen • Fever Reducer/Pain Reliever
Chlorpheniramine Maleate • Antihistamine
Dextromethorphan HBr • Cough Suppressant
Phenylephrine HCl • Nasal Decongestant

Grape
Flavor

4 FL OZ (118 mL)

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Box
PEDIACARE   PLUS MULTISYMPTOM COLD
acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16864-540
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
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:16864-540-011 in 1 BOX07/09/201012/31/2018
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 FINALpart34107/09/201012/31/2018
Labeler - Moberg Pharma North America LLC (192527062)

Revised: 1/2018
 
Moberg Pharma North America LLC