Cvs 44-030 Cc

Cvs 44-030 Cc
SPL v5
SPL
SPL Set ID 44fb27d3-5125-4511-84d2-76555bc46e66
Route
ORAL
Published
Effective Date 2025-04-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (20 mg) Guaifenesin (400 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

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-04-08

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
Principal Display

CVSHealth®

NDC 51316-500-19

MAXIMUM STRENGTH

COUGH &

CONGESTION

DEXTROMETHORPHAN HBr

Cough Suppressant

GUAIFENESIN

Expectorant

Oral Solution

SYMPTOM RELIEF

Controls cough

Relieves chest

congestion & mucus

For Ages 12 & Over

Compare to the active ingredients

in Robitussin® Maximum Strength

Cough + Chest Congestion DM

8 FL OZ

(237 mL)

Menthol-Berry Flavor

CVSHealth®

You have quality

standards. So do we.

Keep your symptoms in

check with quality products

you can trust.

With our CVS Health® brand,

we perform ongoing tests

and monitor customer

feedback to help us exceed

your expectations.

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY

SEAL UNDER CAP IS BROKEN OR MISSING

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2024 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 trademark Robitussin®

Maximum Strength Cough + Chest Congestion DM.

50844 ORG012303019

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

CVS 44-030
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

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 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

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
Principal Display

CVSHealth®

NDC 51316-500-19

MAXIMUM STRENGTH

COUGH &

CONGESTION

DEXTROMETHORPHAN HBr

Cough Suppressant

GUAIFENESIN

Expectorant

Oral Solution

SYMPTOM RELIEF

Controls cough

Relieves chest

congestion & mucus

For Ages 12 & Over

Compare to the active ingredients

in Robitussin® Maximum Strength

Cough + Chest Congestion DM

8 FL OZ

(237 mL)

Menthol-Berry Flavor

CVSHealth®

You have quality

standards. So do we.

Keep your symptoms in

check with quality products

you can trust.

With our CVS Health® brand,

we perform ongoing tests

and monitor customer

feedback to help us exceed

your expectations.

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY

SEAL UNDER CAP IS BROKEN OR MISSING

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2024 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 trademark Robitussin®

Maximum Strength Cough + Chest Congestion DM.

50844 ORG012303019

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

CVS 44-030
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

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 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

Advanced Ingredient Data


Raw Label Data

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