cvs 44-043

cvs 44-043
SPL v4
SPL
SPL Set ID 59d3a486-97c2-4e60-90e2-1b5bfa7638c7
Route
oral
Published
Effective Date 2025-08-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dextromethorphan (30 mg) doxylamine (12.5 mg)
Inactive Ingredients
anhydrous citric acid fd&c blue no. 1 fd&c red no. 40 glycerin high fructose corn syrup polyethylene glycol, unspecified propylene glycol water sodium benzoate sodium chloride trisodium citrate dihydrate sucralose sucrose xanthan gum

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
otc monograph drug active Since 2023-04-14

Purpose

Cough suppressant Antihistamine

Description

Dextromethorphan HBr 30 mg Doxylamine succinate 12.5 mg


Medication Information

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
Purpose

Cough suppressant

Antihistamine

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 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

Description

Dextromethorphan HBr 30 mg Doxylamine succinate 12.5 mg

Principal Display Panel

♥CVS

Health®

Compare to the active

ingredients in Robitussin®

Maximum Strength

Nighttime Cough DM*

MAXIMUM

STRENGTH

MAXIMUM STRENGTH

Nighttime

Tussin DM

DEXTROMETHORPHAN HBr

Cough suppressant

DOXYLAMINE SUCCINATE

Antihistamine

Cough &

Antihistamine

Relieves:

• Cough

• Runny nose

• Sneezing

Menthol-Berry Flavor

Dosage cup

provided

For Ages

12 & Over

Actual Bottle Size

on Side Panel

4 FL OZ (118 mL)

*This product is not manufactured or distributed by

GlaxoSmithKline Consumer Healthcare Holdings (US)

LLC, owner of the registered trademark Robitussin®

Maximum Strength Nighttime Cough DM.

50844    ORG012304336

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

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2023 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

V-19849



♥ 100% money back

guaranteed.


CVS.com/returnpolicy

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

Package Contains One Bottle

Actual Size

CVS 44-043
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.

Questions Or Comments?

1-800-426-9391

When Using This Product
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • 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 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.

Active Ingredients (in Each 20 Ml)

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

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.


Structured Label Content

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
Purpose

Cough suppressant

Antihistamine

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 (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 (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

Principal Display Panel

♥CVS

Health®

Compare to the active

ingredients in Robitussin®

Maximum Strength

Nighttime Cough DM*

MAXIMUM

STRENGTH

MAXIMUM STRENGTH

Nighttime

Tussin DM

DEXTROMETHORPHAN HBr

Cough suppressant

DOXYLAMINE SUCCINATE

Antihistamine

Cough &

Antihistamine

Relieves:

• Cough

• Runny nose

• Sneezing

Menthol-Berry Flavor

Dosage cup

provided

For Ages

12 & Over

Actual Bottle Size

on Side Panel

4 FL OZ (118 mL)

*This product is not manufactured or distributed by

GlaxoSmithKline Consumer Healthcare Holdings (US)

LLC, owner of the registered trademark Robitussin®

Maximum Strength Nighttime Cough DM.

50844    ORG012304336

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

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2023 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

V-19849



♥ 100% money back

guaranteed.


CVS.com/returnpolicy

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

Package Contains One Bottle

Actual Size

CVS 44-043
Do Not Use (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.

Questions Or Comments? (Questions or comments?)

1-800-426-9391

When Using This Product (When using this product)
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • 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 (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away.

Active Ingredients (in Each 20 Ml) (Active ingredients (in each 20 mL))

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

Ask A Doctor Before Use If You Have (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 (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers.


Advanced Ingredient Data


Raw Label Data

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