Cvs Pharmacy, Inc. Severe Tussin Cf Drug Facts

Cvs Pharmacy, Inc. Severe Tussin Cf Drug Facts
SPL v4
SPL
SPL Set ID a26afc33-533e-4dc0-ab25-21be87356e22
Route
ORAL
Published
Effective Date 2024-11-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (650 mg) Dextromethorphan (20 mg) Guaifenesin (400 mg) Phenylephrine (10 mg)
Inactive Ingredients
Anhydrous Citric Acid Benzyl Alcohol Edetate Disodium Fd&c Red No. 40 Glycerin Polyethylene Glycol, Unspecified Propylene Glycol Water Sodium Benzoate Sodium Citrate, Unspecified Form Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-03-24 Until 2024-07-31

Description

Acetaminophen, USP 650 mg Dextromethorphan HBr, USP 20 mg Guaifenesin, USP 400 mg Phenylephrine HCl, USP 10 mg

Purpose

Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant


Medication Information

Purpose

Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant

Description

Acetaminophen, USP 650 mg Dextromethorphan HBr, USP 20 mg Guaifenesin, USP 400 mg Phenylephrine HCl, USP 10 mg

Uses
  • temporarily relieves these symptoms occurring with a cold or flu:
  • cough due to minor throat and bronchial irritation
  • nasal congestion
  • sinus congestion and pressure
  • 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

Nasal decongestant

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, polyethylene glycol, 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
  • you get nervous, dizzy or sleepless
  • pain, cough, or nasal congestion 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, USP 650 mg

Dextromethorphan HBr, USP 20 mg

Guaifenesin, USP 400 mg

Phenylephrine HCl, USP 10 mg

Ask A Doctor Before Use If You Have
  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • 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 Health®

Compare to the active ingredients in Robitussin® Severe Multi-Symptom Cough Cold + Flu

MAXIMUM STRENGTH

Non-Drowsy

Severe Tussin CF

ACETAMINOPHEN

Pain reliever/Fever reducer

DEXTROMETHORPHAN HBr

Cough suppressant

GUAIFENESIN

Expectorant

PHENYLEPHRINE HCl

Nasal decongestant

Adult Cough & Cold

Relieves:

• Cough, sore throat

• Body aches, fever

• Nasal congestion

• Chest congestion

For Ages 12 Years & Over

Dosage cup provided

Package Contains One Bottle

4 FL OZ (118 mL)

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
  • nasal congestion
  • sinus congestion and pressure
  • 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

Nasal decongestant

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, polyethylene glycol, 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)
  • you get nervous, dizzy or sleepless
  • pain, cough, or nasal congestion 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, USP 650 mg

Dextromethorphan HBr, USP 20 mg

Guaifenesin, USP 400 mg

Phenylephrine HCl, USP 10 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • 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 Health®

Compare to the active ingredients in Robitussin® Severe Multi-Symptom Cough Cold + Flu

MAXIMUM STRENGTH

Non-Drowsy

Severe Tussin CF

ACETAMINOPHEN

Pain reliever/Fever reducer

DEXTROMETHORPHAN HBr

Cough suppressant

GUAIFENESIN

Expectorant

PHENYLEPHRINE HCl

Nasal decongestant

Adult Cough & Cold

Relieves:

• Cough, sore throat

• Body aches, fever

• Nasal congestion

• Chest congestion

For Ages 12 Years & Over

Dosage cup provided

Package Contains One Bottle

4 FL OZ (118 mL)

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)