NIGHTTIME COUGH DM- dextromethorphan hbr, doxylamine succinate solution 
L.N.K. International, Inc.

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Quality Plus 44-043

Active ingredients (in each 20 mL)

Dextromethorphan HBr 30 mg
Doxylamine Succinate 12.5 mg

Purpose

Cough suppressant
Antihistamine

Uses

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

  • a cough that occurs with too much phlegm (mucus)
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland
  • a breathing problem or persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • use caution when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

Stop use and ask a doctor if

cough persists more than 7 days, tends to recur, or is accompanied by a fever, rash, or persistent headache. 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

Other information

Inactive ingredients

anhydrous citric acid, FD&C blue #1, FD&C red #40, flavors, glycerin, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucralose, sugar, xanthan gum

Questions or comments?

1-800-426-9391

Principal display panel

NDC 50844-043-36

Quality 
Plus 

Compare to the active ingredients
in Robitussin® MAXIMUM STRENGTH
Nighttime Cough DM*

MAXIMUM STRENGTH

NIGHTTIME
COUGH DM

DEXTROMETHORPHAN HBr
Cough suppressant
DOXYLAMINE SUCCINATE
Antihistamine

• Controls cough
• Relieves runny nose & sneezing

Menthol-Berry
Flavor

Ages 12 Years and Over

4 FL OZ (118 mL)

Dosage cup
included

*This product is not manufactured or
distributed by PF Consumer Healthcare 1 LLC,
owner of the registered trademark Robitussin®
MAXIMUM STRENGTH Nighttime Cough DM.
50844        REV0123A04336

Distributed by
LNK INTERNATIONAL, INC.
60 Arkay Drive
Hauppauge, NY 11788
USA

TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

TAMPER EVIDENT: DO NOT USE IF PRINTED
NECK WRAP IS BROKEN OR MISSING

Quality Plus 44-043

Quality Plus 44-043

NIGHTTIME COUGH DM 
dextromethorphan hbr, doxylamine succinate solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50844-043
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 20 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE12.5 mg  in 20 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SUCROSE (UNII: C151H8M554)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
Colorred (maroon) Score    
ShapeSize
FlavorBERRY, MENTHOLImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50844-043-361 in 1 CARTON07/16/2021
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 DrugM01207/16/2021
Labeler - L.N.K. International, Inc. (038154464)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305manufacture(50844-043) , pack(50844-043)

Revised: 6/2023
Document Id: fb52d1d3-1827-4c78-8ec4-c127afb7c93d
Set id: 75a9c736-bc7e-4b7f-84ea-9474a37508ec
Version: 5
Effective Time: 20230621
 
L.N.K. International, Inc.