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
Purpose

Cough suppressant Expectorant

Description

Dextromethorphan HBr 20 mg Guaifenesin 400 mg

Medication Information

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
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

Description

Dextromethorphan HBr 20 mg Guaifenesin 400 mg

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
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
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

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
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

Back to search View SPL set listing Open on DailyMed ↗

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