Delsym Childrens Night Time description, usages, side effects, indications, overdosage, supplying and lots more!

Delsym Childrens Night Time

Reckitt Benckiser LLC

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Delsym Children's NIGHT TIME COUGH & COLD

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active ingredients (in each 5 mL) Purpose
Diphenhydramine HCl, USP 6.25 mg Antihistamine/Cough suppressant
Phenylephrine HCl, USP 2.5 mg Nasal decongestant

Uses

  • temporarily controls cough due to minor throat and bronchial irritation and relieves nasal congestion as may occur with a cold
  • temporarily relieves the following symptoms due to hay fever or other upper respiratory allergies:
    • sneezing
    • runny nose
    • itchy, watery eyes
    • itchy nose or throat

Warnings

Do not use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on the skin
  • if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

  • heart disease
  • diabetes
  • high blood pressure
  • thyroid disease
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • persistent or chronic cough such as occurs with smoking, asthma or emphysema
  • cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if you are

  • taking sedatives or tranquilizers.

When using this product

  • do not use more than directed
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

  • nervousness, dizziness or sleeplessness occur
  • symptoms do not get better within 7 days or occur with fever
  • cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • do not take more than directed
  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • dose as follows or as directed by a doctor
  • mL = milliliter
Age (year) Dose (mL)
Adults and children 12 years of age and older 20 mL every 4 hours
Children 6 to under 12 years of age 10 mL every 4 hours
Children 4 to under 6 years of age do not use unless directed by a doctor
Children under 4 years of age do not use

Other information

  • each 5 mL contains: sodium 3 mg
  • tamper evident: do not use if printed neckband on bottle cap is broken or missing
  • dosing cup provided
  • store between 20-25°C (68-77°F)
  • Keep carton for full directions for use

Inactive ingredients

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

Questions?

1-888-963-3382

You may also report side effects to this phone number.

Dist. by: Reckitt Benckiser, Parsippany, NJ 07054-0224

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

NOW INCLUDES DOSING FOR AGES 12+

NDC 63824-187-64

Delsym ®

Children's
NIGHT
TIME

COUGH & COLD

Diphenhydramine HCl
(Cough Suppressant/Antihistamine)
Phenylephrine HCl (Nasal Decongestant)

  • Cough
  • Runny Nose
  • Stuffy Nose
  • Sneezing

Grape
Flavored
Liquid

118 mL (4 fl oz)

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

Delsym Childrens Night Time

DIPHENHYDRAMINE HYDROCHLORIDE and PHENYLEPHRINE HYDROCHLORIDE LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63824-187
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
ANHYDROUS CITRIC ACID
EDETATE DISODIUM
FD&C BLUE NO. 1
FD&C RED NO. 40
MALTITOL
propylene glycol
water
SODIUM BENZOATE
SODIUM CITRATE

Product Characteristics

Color
PURPLE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 118 in 1 BOTTLE
2 NDC:63824-187-64 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2011-08-10


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Be sure to consult your doctor before taking any medication!
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