NIGHTTIME COUGH DM- dextromethorphan hbr, doxylamine succinate solution

Nighttime Cough DM by

Drug Labeling and Warnings

Nighttime Cough DM by is a Otc medication manufactured, distributed, or labeled by L.N.K. International, Inc., LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 20 mL)

Dextromethorphan HBr 30 mg
Doxylamine Succinate 12.5 mg

Purpose

Cough suppressant
Antihistamine

Uses

• temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  
• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  
  • itching of the nose or throat 
  • sneezing
    
  • itchy, watery eyes
  • runny nose
    
• controls the impulse to cough to help you 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

• 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

• do not take more than directed
• do not take more than 4 doses in any 24-hour period
  
• mL = milliliter
  
• only use the dose cup provided
• adults and children 12 years and over: 20 mL in dosing cup provided every 6 hours
  
• children under 12 years: do not use
  

Other information

• each 20 mL contains: sodium 14 mg
  
• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  
• see end flap for expiration date and lot number
  

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

INGREDIENTS AND APPEARANCE

NIGHTTIME COUGH DM 
dextromethorphan hbr, doxylamine succinate solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50844-043
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	30 mg  in 20 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	12.5 mg  in 20 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	red (maroon)	Score
Shape		Size
Flavor	BERRY, MENTHOL	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50844-043-36	1 in 1 CARTON	07/16/2021
1		118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	07/16/2021

Labeler - L.N.K. International, Inc. (038154464)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	manufacture(50844-043) , pack(50844-043)