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

Delsym

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 12 Hour Cough Relief Orange

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each 5 mL)

Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide

Purpose

Cough suppressant

Uses

temporarily relieves

  • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
  • 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

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

Stop use and ask a doctor if cough lasts more than 7 days, cough 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

  • shake bottle well before use
  • 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
adults and children 12 years of age and over 10 mL every 12 hours,
not to exceed 20 mL in 24 hours
children 6 to under 12 years of age 5 mL every 12 hours,
not to exceed 10 mL in 24 hours
children 4 to under 6 years of age 2.5 mL every 12 hours,
not to exceed 5 mL in 24 hours
children under 4 years of age do not use

Other information

  • each 5 mL contains: sodium 7 mg
  • store at 20°-25°C (68°-77°F)
  • dosing cup provided

Inactive ingredients

citric acid, edetate disodium, ethylcellulose, FD&C Yellow No. 6, flavor, high fructose corn syrup, methylparaben, polyethylene glycol 3350, polysorbate 80, propylene glycol, propylparaben, purified water, sucrose, tragacanth, vegetable oil, xanthan gum

Questions?

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

Distributed by: Reckitt Benckiser, Parsippany, NJ 07054-0224 ©RB 2011

PRINCIPAL DISPLAY PANEL - 148 mL Bottle Carton

NDC 63824-175-65

Delsym ®

Dextromethorphan Polistirex
Extended-Release Suspension (Cough Suppressant)

COUGH

DAY
OR
NIGHT

12
HOUR
COUGH RELIEF

Orange
Flavored Liquid

148 mL (5 fl oz)

Alcohol-free

PRINCIPAL DISPLAY PANEL - 148 mL Bottle Carton

Delsym

Dextromethorphan SUSPENSION, EXTENDED RELEASE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63824-175
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Dextromethorphan Dextromethorphan 30 mg

Inactive Ingredients

Ingredient Name Strength
Polistirex
CITRIC ACID MONOHYDRATE
EDETATE DISODIUM
ETHYLCELLULOSES
FD&C YELLOW NO. 6
HIGH FRUCTOSE CORN SYRUP
METHYLPARABEN
POLYETHYLENE GLYCOL 3350
polysorbate 80
propylene glycol
PROPYLPARABEN
water
SUCROSE
TRAGACANTH
XANTHAN GUM

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 89 in 1 BOTTLE
2 148 in 1 BOTTLE
3 15 in 1 BOTTLE
4 148 in 1 BOTTLE
5 1 in 1 CARTON
6 NDC:63824-175-22 2 in 1 CELLO PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018658 2010-05-04


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Be sure to consult your doctor before taking any medication!
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