PEDIACARE-COUGH-RUNNYNOSE- acetaminophen,chlorpheniramine maleate,dextromethorphan liquid 
Strides Pharma 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 COUGH AND RUNNY NOSE- acetaminophen, chloropheniramine maleate
and dextromethorphan hydrobromide liquid

Drug Facts

Active ingredients

(in each 5 mL)

Acetaminophen 160 mg

Chlorpheniramine maleate 1 mg

Dextromethorphan HBr 5 mg

Purpose

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

Chlorpheniramine maleate 1 mg……Antihistamine

Dextromethorphan HBr 5 mg………Cough suppressant

Uses

temporarily relieves the following cold/flu symptoms:

Warnings

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

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.

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

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

Do not use

Ask a doctor before use if the child has

Ask a doctor or pharmacist before use if child is taking

When using this product

Stop use and ask a doctor if

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

Weight (lbs)
Age (yrs)
Dose (mL)
under 36
under 4
do not use
36 - 47
4 - 5
do not use unless directed by a doctor
48-95
6-11
10 mL

Other information

Inactive ingredients

citric acid, FD&C red no.40, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose / carboxymethylcellulose sodium, potassium sorbate, purified water, sorbitol, sucralose, xanthan gum.

Questions?

1-888-474-3099

Monday - Friday 8 am to 8 pm EST

PediaCare.com

PRINCIPAL DISPLAY PANEL

PediaCare® Children Cough & Runny Nose

Fever, Sore Throat & Sneezing

4 FL OZ FL (118 mL)

Cherry Flavor

Carton

Carton

Container Label - TOP

Container Label - TOP

Container Label - Base

Container Label - Base

Container Label - Back

Container Label - Back

PEDIACARE-COUGH-RUNNYNOSE 
acetaminophen,chlorpheniramine maleate,dextromethorphan liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59556-852
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
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRY (Cherry Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59556-852-58118 mL in 1 BOTTLE; Type 0: Not a Combination Product07/09/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/09/2010
Labeler - Strides Pharma Inc (078868278)
Establishment
NameAddressID/FEIBusiness Operations
Fareva Richmond, Inc.969523245MANUFACTURE(59556-852) , ANALYSIS(59556-852) , LABEL(59556-852) , PACK(59556-852)

Revised: 8/2017
Document Id: bcc0968d-99b0-4857-886a-c60358ce4b10
Set id: 851ba676-5850-45e5-8fad-6581d066ae3e
Version: 1
Effective Time: 20170807
 
Strides Pharma Inc