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

Delsym

Reckitt Benckiser, Inc.

  • 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 Grape

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each 5 mL teaspoonful)

Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide.

Purpose

Cough suppressant

Use

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

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 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
  • dose as follows or as directed by a doctor.
adults and children 12 years of age and over 2 teaspoonfuls every 12 hours, not to exceed 4 teaspoonfuls in 24 hours
children 6 to under 12 years of age 1 teaspoonful every 12 hours, not to exceed 2 teaspoonfuls in 24 hours
children 4 to under 6 years of age 1/2 teaspoonful every 12 hours, not to exceed 1 teaspoonful in 24 hours
children under 4 years of age do not use

Other information

  • store at 20°-25°C (68°-77°F)

Inactive ingredients

citric acid anhydrous, D&C Red #33, edetate disodium, ethylcellulose, FD&C Blue #1, 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

Distributed by:
Reckitt Benckiser Inc. Parsippany, NJ 07054-0224    ©RBI 2008

PRINCIPAL DISPLAY PANEL - 12 bottles/15 mL Sample Carton

SEE NEW
DIRECTIONS

12 bottles containing
15 mL each

PHYSICIAN SAMPLES —
NOT TO BE SOLD

Delsym®

dextromethorphan polistirex
extended-release suspension

COUGH
SUPPRESSANT

Alcohol-free

Grape-Flavored
Liquid

PRINCIPAL DISPLAY PANEL - 12 bottles/15 mL Sample Carton

Delsym

Dextromethorphan SUSPENSION, EXTENDED RELEASE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63824-271
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

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 15 in 1 BOTTLE
2 NDC:63824-271-75 12 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018658 2008-10-22


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Be sure to consult your doctor before taking any medication!
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