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Delsym12 Hour Cough Relief: Package Insert / Prescribing Info

Package insert / product label
Generic name: dextromethorphan
Dosage form: extended-release suspension
Drug class: Antitussives

Medically reviewed by Drugs.com. Last updated on Aug 24, 2023.

Drug Facts

Active ingredient (in each 5 mL)

Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide

Purpose

Cough suppressant

Indications and Usage for Delsym12 Hour Cough Relief

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 such 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, 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.

Delsym12 Hour Cough Relief Dosage and Administration

  • 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 over10 mL every 12 hours,
not to exceed 20 mL in 24 hours
children 6 to under 12 years of age5 mL every 12 hours,
not to exceed 10 mL in 24 hours
children 4 to under 6 years of age2.5 mL every 12 hours,
not to exceed 5 mL in 24 hours
children under 4 years of agedo not use

Storage and Handling

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

Inactive ingredients

citric acid anhydrous, D&C red no. 33, edetate disodium, ethylcellulose, FD&C blue no. 1, flavor, high fructose corn syrup, methylparaben, partially hydrogenated vegetable oil (soybean, cottonseed), polyethylene glycol 3350, polysorbate 80, propylene glycol, propylparaben, purified water, sucrose, tragacanth, xanthan gum

Questions?

1-866-682-4639
You may also report side effects to this phone number.

Distributed by:
RB Health (US)
Parsippany, NJ
07054-0224

PRINCIPAL DISPLAY PANEL - 148 mL Bottle Carton

NDC 63824-171-65

Delsym®

Dextromethorphan Polistirex
Extended-Release Suspension (Cough Suppressant)

COUGH

12
HOUR
COUGH RELIEF®

Day or Night

Grape
Flavored Liquid

148 mL (5 fl oz)

SULFITE FREE
ALCOHOL FREE

PRINCIPAL DISPLAY PANEL - 148 mL Bottle Carton
DELSYM
dextromethorphan suspension, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-171
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dextromethorphan (UNII: 7355X3ROTS) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide30 mg in 5 mL
Inactive Ingredients
Ingredient NameStrength
Polistirex (UNII: 5H9W9GTW27)
anhydrous citric acid (UNII: XF417D3PSL)
D&C Red NO. 33 (UNII: 9DBA0SBB0L)
edetate disodium (UNII: 7FLD91C86K)
ethylcellulose, unspecified (UNII: 7Z8S9VYZ4B)
FD&C Blue NO. 1 (UNII: H3R47K3TBD)
high fructose corn syrup (UNII: XY6UN3QB6S)
methylparaben (UNII: A2I8C7HI9T)
polyethylene glycol 3350 (UNII: G2M7P15E5P)
polysorbate 80 (UNII: 6OZP39ZG8H)
propylene glycol (UNII: 6DC9Q167V3)
propylparaben (UNII: Z8IX2SC1OH)
water (UNII: 059QF0KO0R)
sucrose (UNII: C151H8M554)
tragacanth (UNII: 2944357O2O)
xanthan gum (UNII: TTV12P4NEE)
Product Characteristics
ColorPURPLEScore
ShapeSize
FlavorGRAPEImprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63824-171-631 in 1 CARTON05/04/2010
189 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
2NDC:63824-171-651 in 1 CARTON05/04/2010
2148 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
3NDC:63824-171-751 in 1 CARTON05/04/2010
315 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
4NDC:63824-171-222 in 1 CELLO PACK05/04/2010
41 in 1 CARTON
4148 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01865805/04/2010
Labeler - RB Health (US) LLC (081049410)

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