COUGH RELIEF- dextromethorphan hbr liquid 
Chain Drug Consortium, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient (in each 5 mL, 1 teaspoon)

Dextromethorphan HBr, USP 15 mg

Purpose

Cough suppressant

Uses

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 on a sodium-restricted diet 
  • 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

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

Stop use and ask a doctor if

cough lasts more than 7 days, comes back, or is accompanied by fever, rash or headache that lasts. These could be signs of a serious condition.

When using this product

  • do not use more than directed

If pregnant or breast-feeding,

ask a health professional before use.

Keep this and all drugs out of the reach of children.

In case of accidental overdose, seek professional assistance or contact a Poison Control Center (1-800-222-1222) immediately.

Directions

  • take recommended dosage or as directed by a doctor
  • tsp = teaspoon, mL = milliliter
age dose 
 adults and children 12 years and over 2 teaspoonfuls every 6-8 hours, not to exceed 4 doses in 24 hours 
 children 6 to under 12 years 1 teaspoonful every 6-8 hours, not to exceed 4 doses in 24 hours
 children 4 to under 6 years do not use unless directed by a doctor
 children under 4 years do not use

Other information

  • each teaspoon contains: sodium 6 mg
  • store at room temperature

Inactive ingredients

citric acid, edetate disodium, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, polyethylene glycol 3350, propylene glycol, purified water, sodium benzoate, sucralose, sucrose, xanthan gum, yellow 6

Questions or comments?

1-866-534-4631

Principal Display Panel

SEE NEW DOSING INFORMATION 

COUGH RELIEF

Cough Suppressant

Dextromehtorphan HBr

Orange Flavor

Alcohol Free

FL OZ (mL)

Contains no fever reducer or pain reliever

This product is not manufactured or distributed by Reckitt Benckiser, distributor of Delsym® Cough Suppressant.

Distributed by: Chain Drug Consortium, LLC.,

3301 NW Boca Raton Blvd., Suite 101

Boca Raton, FL 33431

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL ON THE BOTTLE IS BROKEN OR MISSING.

Package Label

Dextromethorphan HBr 15 mg

Premier Value Cough Relief Liquid, Orange flavor

COUGH RELIEF 
dextromethorphan hbr liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-156
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45)  
GLYCERIN (UNII: PDC6A3C0OX)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SUCROSE (UNII: C151H8M554)  
XANTHAN GUM (UNII: TTV12P4NEE)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Product Characteristics
Color    Score    
ShapeSize
FlavorORANGEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-156-041 in 1 BOX03/30/201112/31/2020
1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34103/30/201112/31/2020
Labeler - Chain Drug Consortium, LLC (101668460)

Revised: 12/2018
Document Id: a36975a8-5ff3-468b-ae4b-e6880615ed4d
Set id: 3fda69b6-a5d6-4676-bca0-891ec81b4a64
Version: 3
Effective Time: 20181204
 
Chain Drug Consortium, LLC