PEDIACARE CHILDRENS COUGH AND CONGESTION- dextromethorphan hydrobromide and guaifenesin liquid

Pediacare Childrens Cough And Congestion by

Drug Labeling and Warnings

Pediacare Childrens Cough And Congestion by is a Otc medication manufactured, distributed, or labeled by Strides Pharma Inc, Fareva Richmond, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

(in each 5 mL)

Dextromehorphan HBr, 5 mg

Guaifenesin, 100 mg

Purpose

Dextromehorphan HBr, 5 mg…….Cough suppressant

Guaifenesin, 100 mg…….………..Expectorant

Uses

• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
• temporarily relieves:
  • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
  • the intensity of coughing
  • the impulse to cough to help your child get to sleep

Warnings

Do not use for 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.

Ask a doctor before use if the child has

• cough that occurs with excessive phlegm (mucus)
• persistent or chronic cough such as occurs with asthma or chronic bronchitis

Stop use and ask a doctor if

• cough gets worse or last more than 7 days
• cough comes back or occurs with fever, rash, or persistent headache.

These could be signs of a serious illness.

When using this product do not use more than directed

Keep out of reach of children

In case of overdose, seek medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

• this product does not contain directions or complete warnings for adult use
• use only the dosing cup provided
• do not exceed 6 doses in a 24-hour period
• mL = milliliter

• Age (yrs): Dose (ml)
• under 4 years: do not use
• 4 to under 6 yrs: 2.5-5 mL every 4 hours
• 6 to 11 yrs: 5-10 mL every 4 hours

Other information

• each 5 mL contains:sodium 3 mg
• store at room temperature
• dosage cup provided

Inactive ingredients

acesulfame potassium, citric acid, FD&C red no. 33, FD&C red no. 40, flavors, glycerin, monoammonium glycyrrhizinate, poloxamer 407, potassium sorbate, propylene glycol, purified water, sodium chloride, sodium citrate, sucralose, sucrose

Questions?

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PRINCIPAL DISPLAY PANEL

PediaCare® Children Cough & Congestion

Non Drowsy

4 FL OZ FL (118 mL)

Cherry Flavor

Carton

Container Label - Top

Container Label - Base

Container Label - Back

INGREDIENTS AND APPEARANCE

PEDIACARE CHILDRENS COUGH AND CONGESTION 
dextromethorphan hydrobromide and guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59556-850
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	5 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
POLOXAMER 407 (UNII: TUF2IVW3M2)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY (Cherry Flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59556-850-58	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/12/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	07/12/2010

Labeler - Strides Pharma Inc (078868278)

Establishment
Name	Address	ID/FEI	Business Operations
Fareva Richmond, Inc.		969523245	MANUFACTURE(59556-850) , ANALYSIS(59556-850) , LABEL(59556-850) , PACK(59556-850)