PediaCare Childrens Nighttime Multi Symptom Cold description, usages, side effects, indications, overdosage, supplying and lots more!

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PediaCare Childrens Nighttime Multi Symptom Cold

Medtech Products Inc

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each 5 mL, 1 teaspoon)

Diphenhydramine HCl 6.25 mg

Phenylephrine HCl 2.5 mg

Purpose

Antihistamine/Cough suppressant

Nasal decongestant

PediaCare Childrens Nighttime Multi Symptom Cold Uses

 temporarily relieves:

  • sneezing
  • runny nose
  • itchy nose or throat
  • itchy, watery eyes due to hay fever
  • nasal and sinus congestion
  • cough due to minor throat and bronchial irritation as may occur with a cold

Warnings

Do not use

  • to make a child sleepy
  • in a child under 4 years of age
  • 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 product containing diphenhydramine, even one used on skin

Ask a doctor before use if the child has

  • glaucoma
  • heart disease
  • high blood pressure
  • diabetes
  • thyroid disease
  • a breathing problem such as chronic bronchitis
  • chronic cough that lasts, or as occurs with asthma
  • cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if the child is

taking sedatives or tranquilizers.

When using this product

  • do not exceed recommended dose
  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness
  • excitability may occur, especially in children

Stop use and ask a doctor if

  • nervousness, dizziness or sleeplessness occurs
  • symptoms do not improve within 7 days or occur with a fever
  • cough persists for more than 7 days, comes back or occurs with a fever, rash or persistent headache

These could be signs of a serious condition.

Keep out of reach of children.

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.
  • if needed, repeat dose every 4 hours
  • do not give more than 6 times in 24 hours unless directed by a doctor
  • tsp = teaspoon; mL = milliliter
 Age (yr) Dose (tsp or mL) 
 under 4 years  do not use
 4 to 5 years  do not use unless directed by a doctor
 6 to 11 years  2 teaspoonfuls (10 mL)

PediaCare Childrens Nighttime Multi Symptom Cold Other information

  • each teaspoon (5 mL) contains: sodium 6 mg
  • store at room temperature. Protect from light. Store in outer carton until contents are used.
  • see bottom panel for lot number and expiration date

Inactive ingredients

acesulfame potassium, benzoic acid, citric acid, edetate disodium, FD&C blue 1, FD&C red 40, flavor, maltitol solution, propylene glycol, purified water, sodium citrate

Questions or comments?

1-888-474-3099

Principal Display Panel

CHILDREN Ages 6-11

PediaCare

Childrens NIGHTTIME MULTI-SYMPTOM Cold

Relieves Stuffy Nose

Soothes Itchy Throat

Controls Cough

Diphenhydramine HCl

Antihistamine/Cough suppressant

Phenylephrine HCl

Nasal decongestant

Grape Flavor

FL OZ (mL)

TAMPER-EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL ON THE BOTTLE IS BROKEN OR MISSING 

KEEP THIS BOX FOR COMPLETE INSTRUCTIONS.

Distributed by Medtech Products Inc.

Irvington, NY 10533, a Prestige Brands Company

Made in USA

www.PediaCare.com

Package Label

PediaCare Childrens Nighttime Multi Symptom Cold

PediaCare Childrens Nighttime Multi-Symptom Cold Grape Liquid
 

PediaCare Childrens Nighttime Multi Symptom Cold

diphenhydramine, phenylephrine LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63029-435
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 6.25 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 2.5 mg

Inactive Ingredients

Ingredient Name Strength
ACESULFAME POTASSIUM
BENZOIC ACID
ANHYDROUS CITRIC ACID
EDETATE DISODIUM
FD&C BLUE NO. 1
FD&C RED NO. 40
MALTITOL
propylene glycol
water
SODIUM CITRATE

Product Characteristics

Color
PURPLE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 118 in 1 BOTTLE
2 NDC:63029-435-04 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2012-06-20


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