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

Delsym

Rebel Distributors Corp

  • 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
Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

Dextromethorphan Polistirex

Purpose

Use(s)

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

Keep Out of Reach of Children

Uses

Use(s)

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

Warnings

Do not use

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)

Ask a doctor or pharmacist before use if you are

When using this product

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

Keep out of reach of children

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

Directions

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

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

Drug Facts

Distributed by: Reckitt Benckiser Inc., Parsippany, NJ 07054-0224 ©RBI 2009

Inactive ingredients

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

Package/Label Principal Display Panel

Package/Label Principal Display Panel

Package/Label Principal Display Panel

Package/Label Principal Display Panel

Delsym

Dextromethorphan Polistirex SYRUP

Product Information

Product Type Human otc drug label Item Code (Source) NDC:21695-517(NDC:63824-171)
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
CITRIC ACID MONOHYDRATE
D&C RED NO. 33
EDETATE DISODIUM
ETHYLCELLULOSES
FD&C BLUE NO. 1
HIGH FRUCTOSE CORN SYRUP
METHYLPARABEN
POLYETHYLENE GLYCOL 3350
polysorbate 80
propylene glycol
PROPYLPARABEN
water
SUCROSE
TRAGACANTH
CORN OIL
XANTHAN GUM

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:21695-517-30 90 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018658 2009-09-04


Delsym

Dextromethorphan Polistirex SYRUP

Product Information

Product Type Human otc drug label Item Code (Source) NDC:21695-518(NDC:63824-172)
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
CITRIC ACID MONOHYDRATE
D&C RED NO. 33
EDETATE DISODIUM
ETHYLCELLULOSES
FD&C BLUE NO. 1
HIGH FRUCTOSE CORN SYRUP
METHYLPARABEN
POLYETHYLENE GLYCOL 3350
polysorbate 80
propylene glycol
PROPYLPARABEN
water
SUCROSE
TRAGACANTH
CORN OIL
XANTHAN GUM

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:21695-518-30 90 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018658 2009-09-04


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