DELSYM- dextromethorphan suspension, extended release 
REMEDYREPACK INC.

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Delsym

12 Hour Cough Relief

Grape

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 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.

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 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

Other information

  • 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.

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

DRUG: Delsym

GENERIC: Dextromethorphan

DOSAGE: SUSPENSION, EXTENDED RELEASE

ADMINSTRATION: ORAL

NDC: 70518-1912-0

COLOR: purple

FLAVOR: GRAPE

PACKAGING: 89 mL in 1 BOTTLE

OUTER PACKAGING: 1 in 1 CARTON

ACTIVE INGREDIENT(S):

  • Dextromethorphan 30mg in 5mL

INACTIVE INGREDIENT(S):

  • Polistirex
  • anhydrous citric acid
  • D&C Red NO. 33
  • edetate disodium
  • ethylcellulose, unspecified
  • FD&C Blue NO. 1
  • high fructose corn syrup
  • methylparaben
  • polyethylene glycol 3350
  • polysorbate 80
  • propylene glycol
  • propylparaben
  • water
  • sucrose
  • tragacanth
  • xanthan gum

Remedy_Label

DELSYM 
dextromethorphan suspension, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70518-1912(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:70518-1912-01 in 1 CARTON03/04/201910/16/2023
189 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
NDANDA01865803/04/201910/16/2023
Labeler - REMEDYREPACK INC. (829572556)

Revised: 10/2023
Document Id: 07d568fe-4527-fff1-e063-6294a90a2165
Set id: fcd03fa7-f7fd-4ddc-aae0-be883f0c7b33
Version: 8
Effective Time: 20231016
 
REMEDYREPACK INC.