Your browser does not support JavaScript! PEDIACARE CHILDRENS ALLERGY AND COLD (DIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [BLACKSMITH BRANDS, INC.]
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PEDIACARE CHILDRENS ALLERGY AND COLD (diphenhydramine hydrochloride and phenylephrine hydrochloride) liquid
[Blacksmith Brands, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

PediaCare Children’s Allergy & Cold

Drug Facts

Active ingredients (in each 5 mL)*

Diphenhydramine HCl 12.5 mg

Purposes

Antihistamine/cough suppressant

Active ingredients (in each 5 mL)*

Phenylephrine HCl 5 mg

Purposes

Nasal decongestant

*5 mL = one teaspoon

Uses

  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • runny nose
  • sneezing
  • itchy, watery eyes
  • nasal congestion
  • itching of the nose or throat
  • temporarily relieves these symptoms due to the common cold:
  • runny nose
  • sneezing
  • nasal congestion
  • cough

Warnings

Do not use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
  • 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

Ask a doctor before use

if the child has

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

Ask a doctor or pharmacist before use

if the child is taking sedatives or tranquilizers

When using this product

  • do not exceed recommended dose
  • excitability may occur, 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
  • symptoms do not improve within 7 days or occur with a fever
  • cough gets worse or lasts for more than 7 days
  • cough tends to come back or occurs with fever, rash or headache that lasts

These could be signs of a serious condition.

Keep out of reach of children

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

Directions

  • find right dose on chart below
  • use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
  • take every 4 hours
  • do not take more than 6 doses in 24 hours
Age (yr)Dose (tsp)
Under 4 yearsDo not use
4 to 5 yearsDo not use unless directed by a doctor
6 to 11 years1 teaspoonful

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other information

  • each teaspoon contains: sodium 10 mg
  • store between 20-25°C (68-77°F). Protect from light.
  • do not use if bottle wrap, or foil inner seal imprinted “Safety Seal®” is broken or missing
  • see bottom panel for lot number and expiration date

Store in outer carton until contents are used.

Inactive ingredients

anhydrous citric acid, carboxymethylcellulose sodium, edetate disodium, FD&C blue #1, FD&C red #40, flavors, glycerin, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

Questions or comments?

call 1-888-474-3099

PRINCIPAL DISPLAY PANEL

See New Warnings & Directions
PediaCare
Children’s

Allergy & Cold

Phenylephrine HCI, Diphenhydramine HCI
4 FL OZ (118
mL)

PRINCIPAL DISPLAY PANEL
PediaCare Children’s Allergy & Cold
Phenylephrine HCI, Diphenhydramine HCI
4 FL OZ (118 mL)

PEDIACARE CHILDRENS ALLERGY AND COLD 
diphenhydramine hydrochloride and phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:52183-389
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 5 mL
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
CARBOXYMETHYLCELLULOSE SODIUM 
EDETATE DISODIUM 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GLYCERIN 
WATER 
SODIUM BENZOATE 
SODIUM CITRATE 
SORBITOL 
SUCRALOSE 
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52183-389-041 in 1 CARTON
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34110/29/2009
Labeler - Blacksmith Brands, Inc. (021411299)
Establishment
NameAddressID/FEIBusiness Operations
Trillium Healthcare Products, Inc.255426306MANUFACTURE

Revised: 8/2010
 
Blacksmith Brands, Inc.

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