6044-cvs

6044-cvs
SPL v2
SPL
SPL Set ID 31aa77e0-cfdb-57a8-e063-6394a90af98c
Route
ORAL
Published
Effective Date 2025-09-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (15 mg) Acetaminophen (500 mg) Chlorpheniramine (2 mg)
Inactive Ingredients
Crospovidone Polyethylene Glycol, Unspecified Fd&c Blue No. 2 Aluminum Lake Hypromelloses Magnesium Stearate Povidone Sodium Starch Glycolate Type A Stearic Acid Starch, Corn Titanium Dioxide Microcrystalline Cellulose Triacetin Mineral Oil Medium-chain Triglycerides Talc Polydextrose Fd&c Red No. 40 Aluminum Lake

Identifiers & Packaging

Pill Appearance
Imprint: C642 Shape: oval Color: blue Color: red Size: 18 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-10

Description

Daytime Flu Relief Maximum Strength


Medication Information

Warnings and Precautions

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.

Description

Daytime Flu Relief Maximum Strength

Uses
  • temporarily relieves these symptoms due to a common cold or flu:
    • headache
    • minor aches and pains
    • cough due to minor throat and bronchial irritation
    • minor sore throat pain
  • temporarily reduces fever
Section 34088-5

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

Section 42229-5

Daytime Flu Relief Maximum Strength

Section 50565-1

Keep out of reach of children.

Section 50566-9
  • 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 a rash or headache that lasts

These could be signs of a serious condition.

Section 50567-7

When using this product do not use more than directed.

Section 50568-5
  • taking the blood thinning drug warfarin
Section 50569-3
  • liver disease
  • a breathing problem such as emphysema or chronic bronchitis
  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
Section 50570-1
  • in a child under 12 years of age
  • if you are allergic to acetaminophen
  • 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 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.
Section 51727-6

corn starch, crospovidone, FD&C blue #2 lake, FD&C red #40 lake, hypromellose, magnesium stearate, medium chain triglycerides,

microcrystalline cellulose, mineral oil, polydextrose, polyethylene glycol, povidone, sodium starch glycolate, stearic acid, talc, titanium dioxide.

Section 51945-4

CVS™

NDC 51316-984-03

Compare to Theraflu® Flu Relief Max Strength Daytime & Nighttime active ingredients*

Maximum Strength†

DAYTIME FLU RELIEF

Acetaminophen

Pain Reliever, Fever Reducer

Dextromethorphan HBr

Cough Suppressant

Relieves: Fever, Body aches, Headache, Sore throat pain, Cough

20 DAYTIME CAPLETS

Maximum Strength†

NIGHTTIME FLU RELIEF

Acetaminophen

Pain Reliever, Fever Reducer

Chlorpheniramine Maleate,

Antihistamine

Dextromethorphan HBr

Cough Suppressant

Additional Nighttime Relief of: Runny nose

20 NIGHTTIME CAPLETS

40 TOTAL CAPLETS

†Maximum Strength per 6 hour dose under OTC monograph.

Section 53413-1

1-800-231-4670

Section 53414-9

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

Section 55105-1

Purposes

Pain reliever/Fever reducer

Cough suppressant

Directions
  • do not use more than directed
  • adults and children 12 years of age and over: take 2 caplets every 6 hours, while symptoms persist
  • do not take more than 6 caplets in 24 hours unless directed by a doctor
  • children under 12 years of age: do not use
    Age Dose
    adults and children 12 years of age and over 2 caplets every 6 hours
    children under 12 years of age do not use

Drug Facts

Active ingredients (in each caplet)

Acetaminophen 500 mg

Dextromethorphan HBr 15 mg

Drug Facts

Active ingredients (in each caplet)

Acetaminophen 500 mg

Chlorpheniramine maleate 2 mg

Dextromethorphan HBr 15 mg

Other Information

Store in a dry place at 15º - 30°C (59° -86°F).


Structured Label Content

Uses
  • temporarily relieves these symptoms due to a common cold or flu:
    • headache
    • minor aches and pains
    • cough due to minor throat and bronchial irritation
    • minor sore throat pain
  • temporarily reduces fever
Warnings and Precautions (34071-1)

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.

Section 34088-5 (34088-5)

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

Section 42229-5 (42229-5)

Daytime Flu Relief Maximum Strength

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)
  • 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 a rash or headache that lasts

These could be signs of a serious condition.

Section 50567-7 (50567-7)

When using this product do not use more than directed.

Section 50568-5 (50568-5)
  • taking the blood thinning drug warfarin
Section 50569-3 (50569-3)
  • liver disease
  • a breathing problem such as emphysema or chronic bronchitis
  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
Section 50570-1 (50570-1)
  • in a child under 12 years of age
  • if you are allergic to acetaminophen
  • 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 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.
Section 51727-6 (51727-6)

corn starch, crospovidone, FD&C blue #2 lake, FD&C red #40 lake, hypromellose, magnesium stearate, medium chain triglycerides,

microcrystalline cellulose, mineral oil, polydextrose, polyethylene glycol, povidone, sodium starch glycolate, stearic acid, talc, titanium dioxide.

Section 51945-4 (51945-4)

CVS™

NDC 51316-984-03

Compare to Theraflu® Flu Relief Max Strength Daytime & Nighttime active ingredients*

Maximum Strength†

DAYTIME FLU RELIEF

Acetaminophen

Pain Reliever, Fever Reducer

Dextromethorphan HBr

Cough Suppressant

Relieves: Fever, Body aches, Headache, Sore throat pain, Cough

20 DAYTIME CAPLETS

Maximum Strength†

NIGHTTIME FLU RELIEF

Acetaminophen

Pain Reliever, Fever Reducer

Chlorpheniramine Maleate,

Antihistamine

Dextromethorphan HBr

Cough Suppressant

Additional Nighttime Relief of: Runny nose

20 NIGHTTIME CAPLETS

40 TOTAL CAPLETS

†Maximum Strength per 6 hour dose under OTC monograph.

Section 53413-1 (53413-1)

1-800-231-4670

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purposes

Pain reliever/Fever reducer

Cough suppressant

Directions
  • do not use more than directed
  • adults and children 12 years of age and over: take 2 caplets every 6 hours, while symptoms persist
  • do not take more than 6 caplets in 24 hours unless directed by a doctor
  • children under 12 years of age: do not use
    Age Dose
    adults and children 12 years of age and over 2 caplets every 6 hours
    children under 12 years of age do not use

Drug Facts

Active ingredients (in each caplet)

Acetaminophen 500 mg

Dextromethorphan HBr 15 mg

Drug Facts (Drug facts)

Active ingredients (in each caplet)

Acetaminophen 500 mg

Chlorpheniramine maleate 2 mg

Dextromethorphan HBr 15 mg

Other Information (Other information)

Store in a dry place at 15º - 30°C (59° -86°F).


Advanced Ingredient Data


Raw Label Data

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