Cvs 44-030043

Cvs 44-030043
SPL v4
SPL
SPL Set ID d59f6c64-8311-48ba-90d1-8000b04bfcda
Route
ORAL
Published
Effective Date 2025-08-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (20 mg) Guaifenesin (400 mg) Doxylamine (30 mg)
Inactive Ingredients
Anhydrous Citric Acid Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin High Fructose Corn Syrup Microcrystalline Cellulose Polyethylene Glycol, Unspecified Propylene Glycol Water Sodium Benzoate Sodium Chloride Trisodium Citrate Dihydrate Sorbitol Sucralose Xanthan Gum Sucrose

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-04-18
Description

Dextromethorphan HBr 20 mg Guaifenesin 400 mg

Purpose

Cough suppressant Expectorant

Medication Information

Purpose

Cough suppressant

Expectorant

Description

Dextromethorphan HBr 20 mg Guaifenesin 400 mg

Uses
  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
Directions
  • do not take more than directed
  • do not take more than 6 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 4 hours
  • children under 12 years: 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.

Other Information
  • each 20 mL contains: sodium 16 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, microcrystalline cellulose, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sorbitol, sucralose, xanthan gum

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
Principal Display Panel 

DAY & NIGHT COMBO PACK

♥CVS

Health®

Compare to the active

ingredients in Robitussin®

Maximum Strength Cough

+ Chest Congestion DM*

MAXIMUM

STRENGTH

MAXIMUM STRENGTH

FOR MUCUS RELIEF

Daytime Non-Drowsy

Tussin DM

DEXTROMETHORPHAN HBr

Cough suppressant

GUAIFENESIN

Expectorant

Cough & Chest

Congestion

Relieves:

• Cough

• Chest congestion

• Mucus

Menthol-Berry Flavor

Dosage cup

provided

For Ages

12 & Over

Actual Bottle Size

on Side Panel

4 FL OZ (118 mL) + 4 FL OZ (118 mL)

TOTAL 8 FL OZ (236 mL)

♥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

DO NOT TAKE DAYTIME AND NIGHTTIME

PRODUCTS AT THE SAME TIME

TAMPER EVIDENT: DO NOT USE IF PRINTED

NECK WRAP IS BROKEN OR MISSING

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR

MISSING

50844     ORG012303004336

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

*This product is not manufactured or distributed

by GlaxoSmithKline Consumer Healthcare

Holdings (US) LLC, owner of the registered

trademarks Robitussin® Maximum Strength

Cough + Chest Congestion DM and Robitussin®

Maximum Strength Nighttime Cough DM.

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

Package Contains Two Bottles

Actual Size

CVS 44-030043
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.

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 20 mg

Guaifenesin 400 mg

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, 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
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
Purpose

Cough suppressant

Expectorant

Directions
  • do not take more than directed
  • do not take more than 6 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 4 hours
  • children under 12 years: do not use
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.

Other Information (Other information)
  • each 20 mL contains: sodium 16 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 (Inactive ingredients)

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

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
Principal Display Panel 

DAY & NIGHT COMBO PACK

♥CVS

Health®

Compare to the active

ingredients in Robitussin®

Maximum Strength Cough

+ Chest Congestion DM*

MAXIMUM

STRENGTH

MAXIMUM STRENGTH

FOR MUCUS RELIEF

Daytime Non-Drowsy

Tussin DM

DEXTROMETHORPHAN HBr

Cough suppressant

GUAIFENESIN

Expectorant

Cough & Chest

Congestion

Relieves:

• Cough

• Chest congestion

• Mucus

Menthol-Berry Flavor

Dosage cup

provided

For Ages

12 & Over

Actual Bottle Size

on Side Panel

4 FL OZ (118 mL) + 4 FL OZ (118 mL)

TOTAL 8 FL OZ (236 mL)

♥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

DO NOT TAKE DAYTIME AND NIGHTTIME

PRODUCTS AT THE SAME TIME

TAMPER EVIDENT: DO NOT USE IF PRINTED

NECK WRAP IS BROKEN OR MISSING

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR

MISSING

50844     ORG012303004336

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

*This product is not manufactured or distributed

by GlaxoSmithKline Consumer Healthcare

Holdings (US) LLC, owner of the registered

trademarks Robitussin® Maximum Strength

Cough + Chest Congestion DM and Robitussin®

Maximum Strength Nighttime Cough DM.

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

Package Contains Two Bottles

Actual Size

CVS 44-030043
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.

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 20 mg

Guaifenesin 400 mg

Ask A Doctor Before Use If You Have (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, 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

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:48.770496 · Updated: 2026-03-14T23:09:46.965889