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

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Childrens Delsym

Reckitt Benckiser LLC

Children's Delsym Cough Plus™ Chest Congestion DM


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active ingredients (in each 5 mL) Purposes
Dextromethorphan HBr 5 mg Cough suppressant
Guaifenesin 100 mg Expectorant

Childrens Delsym 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 you get to sleep

Warnings

Do not use 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

  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough that occurs with too much phlegm (mucus)

When using this product do not use more than directed

Stop use and ask a doctor if

  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. 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 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 10 mL - 20 mL every 4 hours
children 6 to under 12 years of age 5 mL - 10 mL every 4 hours
children 4 to under 6 years of age 2.5 mL - 5 mL every 4 hours
children under 4 years of age do not use

Childrens Delsym Other information

  • each 5 mL contains:
    sodium 4 mg
  • tamper evident: do not use if neckband on bottle cap is broken or missing
  • store between 20-25°C (68-77°F)
  • do not refrigerate
  • dosing cup provided

Inactive ingredients

anhydrous citric acid, edetate disodium, FD&C Red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydratemay contain this ingredient, xanthan gum

Questions?

1-888-963-3382
You may also report side effects to this phone number.

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

PRINCIPAL DISPLAY PANEL - 180 mL Bottle Label

031113
8079219

Children's
Delsym®

NDC 63824-214-66

COUGH + ™
CHEST
CONGESTION

DM

Dextromethorphan HBr (Cough Suppressant)
Guaifenesin (Expectorant)

Age 4+

  • ✓ Cough
  • ✓ Chest Congestion
  • ✓ Thins & Loosens
    Mucus

6 fl oz (180 mL)

Cherry Flavor

Childrens Delsym

Childrens Delsym

Dextromethorphan Hydrobromide and Guaifenesin LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63824-214
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 5 mg
Guaifenesin GUAIFENESIN 100 mg

Inactive Ingredients

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

Product Characteristics

Color
RED

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:63824-214-66 180 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2013-03-31


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Be sure to consult your doctor before taking any medication!
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