Cvs Pharmacy, Inc. Severe Cough Cold & Flu Drug Facts

Cvs Pharmacy, Inc. Severe Cough Cold & Flu Drug Facts
SPL v2
SPL
SPL Set ID 67f8d405-a2ad-4ade-93b4-9b09a0d81d8e
Route
ORAL
Published
Effective Date 2025-09-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (650 mg) Dextromethorphan (20 mg) Guaifenesin (400 mg)
Inactive Ingredients
Anhydrous Citric Acid Benzyl Alcohol Edetate Disodium Fd&c Red No. 40 Glycerin Propylene Glycol Water Sodium Benzoate Sodium Citrate, Unspecified Form Sorbitol Solution Sucralose Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-29

Description

Acetaminophen 650 mg Dextromethorphan HBr 20 mg Guaifenesin 400 mg

Purpose

Pain reliever/fever reducer Cough suppressant Expectorant


Medication Information

Purpose

Pain reliever/fever reducer Cough suppressant Expectorant

Description

Acetaminophen 650 mg Dextromethorphan HBr 20 mg Guaifenesin 400 mg

Uses
  • temporarily relieves these symptoms occurring with a cold or flu:
    • cough due to minor throat and bronchial irritation
    • minor aches and pains
    • sore throat
    • headache
  • temporarily reduces fever
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
Purposes

Pain reliever/fever reducer

Cough suppressant

Expectorant

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Directions
  • do not take more than 5 doses in any 24-hour period
  • do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage.
  • measure only with dosing cup provided
  • keep dosing cup with product
  • mL = milliliter
  • this adult product is not intended for use in children under 12 years of age

age

dose

adults and children

12 years and over

20 mL 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.
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you have ever had an allergic reaction to this product or any of its ingredients
Other Information
  • each 20 mL contains: sodium 14 mg
  • store at 20-25°C (68-77°F). Do not refrigerate.
Inactive Ingredients

anhydrous citric acid, benzyl alcohol, edetate disodium, FD&C red #40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, xanthan gum

Questions Or Comments?

1-800-719-9260

Stop Use and Ask A Doctor If
  • pain or cough gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back or occurs with rash or headache that lasts. 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.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Active Ingredients (in Each 20 Ml)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Ask A Doctor Before Use If You Have
  • liver disease
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Package/label Principal Display Panel

CVS

Raspberry Flavor

Maximum Strength

SEVERE COUGH COLD & FLU

Acetaminophen

Pain Reliever, Fever Reducer

Dextromethorphan HBr

Cough Suppressant

Guaifenesin

Expectorant

Compare to Robitussin® Maximum Strength Severe Multi-Symptom Cough Cold + Flu active ingredients

Relieves: Cough, Sore throat, Body aches, Fever, Chest congestion

For Adults & Children Ages 12 & Over

New Formula

8 FL OZ (237 mL)

Maximum strength claim based on maximum levels of active ingredients per 4 hour dose.

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin


Structured Label Content

Uses
  • temporarily relieves these symptoms occurring with a cold or flu:
    • cough due to minor throat and bronchial irritation
    • minor aches and pains
    • sore throat
    • headache
  • temporarily reduces fever
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
Purposes

Pain reliever/fever reducer

Cough suppressant

Expectorant

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Directions
  • do not take more than 5 doses in any 24-hour period
  • do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage.
  • measure only with dosing cup provided
  • keep dosing cup with product
  • mL = milliliter
  • this adult product is not intended for use in children under 12 years of age

age

dose

adults and children

12 years and over

20 mL 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.
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you have ever had an allergic reaction to this product or any of its ingredients
Other Information (Other information)
  • each 20 mL contains: sodium 14 mg
  • store at 20-25°C (68-77°F). Do not refrigerate.
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, benzyl alcohol, edetate disodium, FD&C red #40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, xanthan gum

Questions Or Comments? (Questions or comments?)

1-800-719-9260

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • pain or cough gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back or occurs with rash or headache that lasts. 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.)

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • liver disease
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Package/label Principal Display Panel (Package/Label principal display panel)

CVS

Raspberry Flavor

Maximum Strength

SEVERE COUGH COLD & FLU

Acetaminophen

Pain Reliever, Fever Reducer

Dextromethorphan HBr

Cough Suppressant

Guaifenesin

Expectorant

Compare to Robitussin® Maximum Strength Severe Multi-Symptom Cough Cold + Flu active ingredients

Relieves: Cough, Sore throat, Body aches, Fever, Chest congestion

For Adults & Children Ages 12 & Over

New Formula

8 FL OZ (237 mL)

Maximum strength claim based on maximum levels of active ingredients per 4 hour dose.

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

taking the blood thinning drug warfarin


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)