COUGH DM NIGHTTIME- dextromethorphan hbr, doxylamine succinate solution

Cough DM by

Drug Labeling and Warnings

Cough DM by is a Otc medication manufactured, distributed, or labeled by CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED, 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
  • itchy, watery eyes
  • runny nose
  • sneezing
• 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 such as emphysema or chronic bronchitis
• persistent or chronic cough such as occurs with smoking, asthma, or emphysema

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

• marked drowsiness may occur
• avoid alcoholic beverages
• alcohol, sedatives, and tranquilizers may increase drowsiness
• 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 1 week, 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 every 6 hours
• children under 12 years: do not use

Other information

• each 20 mL contains: sodium 14 mg
  
• store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
• 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: 51316-431-36

♥CVS™

Menthol Berry
Flavor

Maximum Strength†
NIGHTTIME
COUGH
DM

Dextromethorphan HBr
Cough Suppressant
Doxylamine Succinate
Antihistamine
Oral Solution

Compare to Robitussin®
Maximum Strength Nighttime
Cough DM active ingredients*

Relieves: Cough,
Runny nose, Sneezing
Ages 12 & Over
dosing cup included

4 FL OZ (118 mL)
†Under OTC monograph.

package contains one bottle
actual size

*This product is not manufactured or distributed by Haleon
US Holdings LLC, owner of the registered trademark
Robitussin® Maximum Strength Nighttime Cough DM.

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

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2025 CVS/pharmacy
CVS.com® 1-800-SHOP CVS
V-19849

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guaranteed.
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50844 ORG122404336

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CVS 44-043

INGREDIENTS AND APPEARANCE

COUGH DM  NIGHTTIME
dextromethorphan hbr, doxylamine succinate solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51316-431
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	MENTHOL, BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51316-431-36	1 in 1 CARTON	02/25/2026
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	02/25/2026

Labeler - CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED (062312574)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	manufacture(51316-431) , pack(51316-431)