Cvs Severe Daytime Cough, Flu+sore Throat Drug Facts

Cvs Severe Daytime Cough, Flu+sore Throat Drug Facts
SPL v5
SPL
SPL Set ID 95203001-7ca6-4513-83a3-9ef17855bc0f
Route
ORAL
Published
Effective Date 2025-12-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (650 mg) Dextromethorphan (20 mg)
Inactive Ingredients
Anhydrous Citric Acid Carboxymethylcellulose Sodium, Unspecified Edetate Disodium American Elderberry Glycerin Honey Polyethylene Glycol, Unspecified Propylene Glycol Water Sodium Benzoate Sodium Citrate, Unspecified Form Sucralose Xanthan Gum Zinc Gluconate

Identifiers & Packaging

Pill Appearance
Color: orange
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-02-17

Description

Acetaminophen, USP 650 mg Dextromethorphan HBr, USP 20 mg

Purpose

Pain reliever/Fever reducer Cough suppressant


Medication Information

Warnings and Precautions

Warnings

Indications and Usage

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 pain
    • headache
  • temporarily reduces fever
Purpose

Pain reliever/Fever reducer Cough suppressant

Dosage and Administration

Directions

  • do not take more than 6 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

Description

Acetaminophen, USP 650 mg Dextromethorphan HBr, USP 20 mg

Section 42229-5

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.

Section 44425-7

Other information

  • each 20 ml contains: sodium 10 mg
  • store at room temperature
Section 50565-1

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.

Section 50567-7

When using this product do not use more than directed.

Section 51727-6

Inactive ingredients

anhydrous citric acid, carboxymethylcellulose sodium, disodium edetate, elderberry extract, flavors, glycerin, organic wildflower honey, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose, xanthan gum, zinc gluconate

Section 53413-1

Questions or comments?

1-866-467-2748

Section 53414-9

If pregnant or breast-feeding,ask a health professional before use.

Purposes

Pain reliever/Fever reducer

Cough suppressant

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.
Liver Warning

This product contains acetaminophen.

Severe liver damage may occur if you take

  • more than 6 doses in any 24-hour period, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product
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.

Principal Display Panel

NDC 51316-631-08

SEVERE

Daytime

Cough, Flu +

Sore Throat

With Honey

Acetaminophen (Pain Reliever/Fever Reducer)

Dextromethorphan HBr (Cough Suppressant)

Maximum Strength

  • Controls Cough
  • Soothes Sore Throat Pain
  • Relieves Fever & Body Aches

Taste the Real Honey

with Elderberry

CFMAX

For Ages 12 & Over

8 FL OZ (237 ml)

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.
Active Ingredients (in Each 20 Ml)

Acetaminophen, USP 650 mg

Dextromethorphan HBr, USP 20 mg

Ask A Doctor Before Use If You Have
  • liver disease
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, or emphysema
Ask A Doctor Or Pharmacist Before Use If You Are
  • taking the blood thinning drug warfarin
  • taking any other pain reliever/fever reducer

Structured Label Content

Indications and Usage (34067-9)

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 pain
    • headache
  • temporarily reduces fever
Dosage and Administration (34068-7)

Directions

  • do not take more than 6 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

Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

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.

Section 44425-7 (44425-7)

Other information

  • each 20 ml contains: sodium 10 mg
  • store at room temperature
Section 50565-1 (50565-1)

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.

Section 50567-7 (50567-7)

When using this product do not use more than directed.

Section 51727-6 (51727-6)

Inactive ingredients

anhydrous citric acid, carboxymethylcellulose sodium, disodium edetate, elderberry extract, flavors, glycerin, organic wildflower honey, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose, xanthan gum, zinc gluconate

Section 53413-1 (53413-1)

Questions or comments?

1-866-467-2748

Section 53414-9 (53414-9)

If pregnant or breast-feeding,ask a health professional before use.

Purposes

Pain reliever/Fever reducer

Cough suppressant

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.
Liver Warning (Liver warning)

This product contains acetaminophen.

Severe liver damage may occur if you take

  • more than 6 doses in any 24-hour period, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product
Sore Throat Warning (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.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 51316-631-08

SEVERE

Daytime

Cough, Flu +

Sore Throat

With Honey

Acetaminophen (Pain Reliever/Fever Reducer)

Dextromethorphan HBr (Cough Suppressant)

Maximum Strength

  • Controls Cough
  • Soothes Sore Throat Pain
  • Relieves Fever & Body Aches

Taste the Real Honey

with Elderberry

CFMAX

For Ages 12 & Over

8 FL OZ (237 ml)

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.
Active Ingredients (in Each 20 Ml) (Active ingredients (in each 20 ml))

Acetaminophen, USP 650 mg

Dextromethorphan HBr, USP 20 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)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, or emphysema
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
  • taking any other pain reliever/fever reducer

Advanced Ingredient Data


Raw Label Data

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