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Delsym

Reckitt Benckiser, Inc.

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 12.5 mg Antihistamine/Cough suppressant
Phenylephrine HCl 5 mg Nasal decongestant

Delsym 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 over 10 mL every 4 hours
children 6 to under 12 years of age 5 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

Delsym Other information

  • each 5 mL contains: sodium 10 mg
  • tamper evident: do not use if neckband on bottle cap is broken or missing
  • dosing cup provided
  • store between 15-30°C (59-86°F)
  • Keep carton for full directions for use

Inactive ingredients

anhydrous citric acid, anhydrous trisodium citrate, carboxymethylcellulose sodium, edetate disodium, FD&C Blue #1, FD&C Red #40, flavors, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose

Questions?

1-888-963-3382

You may also report side effects to this phone number.

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

PRINCIPAL DISPLAY PANEL - 118 mL Carton

SEE NEW INGREDIENTS

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)

Delsym

Delsym

Diphenhydramine Hydrochloride and Phenylephrine Hydrochloride SOLUTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63824-184
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 12.5 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg

Inactive Ingredients

Ingredient Name Strength
ANHYDROUS CITRIC ACID
ANHYDROUS TRISODIUM CITRATE
CARBOXYMETHYLCELLULOSE SODIUM
EDETATE DISODIUM
FD&C BLUE NO. 1
FD&C RED NO. 40
GLYCERIN
PROPYL GALLATE
propylene glycol
water
SODIUM BENZOATE
sorbitol
Sucralose

Product Characteristics

Color
PURPLE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 118 in 1 BOTTLE
2 NDC:63824-184-64 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2010-04-29


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Be sure to consult your doctor before taking any medication!
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