Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID b765c82e-5021-4772-8647-c5ebc596bc0a
Route
ORAL
Published
Effective Date 2025-07-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (650 mg) Dextromethorphan (30 mg) Doxylamine (12.5 mg)
Inactive Ingredients
Propylene Glycol Water Alcohol Anhydrous Citric Acid High Fructose Corn Syrup Polyethylene Glycol, Unspecified Saccharin Sodium Trisodium Citrate Dihydrate D&c Yellow No. 10 Fd&c Green No. 3 Fd&c Yellow No. 6 Acesulfame Potassium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-03-15

Description

Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine succinate 12.5 mg

Purpose

Pain reliever/fever reducer Cough suppressant Antihistamine


Medication Information

Purpose

Pain reliever/fever reducer Cough suppressant Antihistamine

Description

Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine succinate 12.5 mg

Uses

temporarily relieves these common cold/flu symptoms:

  • minor aches and pains
  • headache
  • sore throat
  • fever
  • runny nose and sneezing
  • cough due to minor throat and bronchial irritation
Purposes

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Warnings

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

  • more than 4,000 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 directed (see Overdose warning)

  • do not take more than 4 doses in 24-hours period

  • measure only with dosing cup provided. Do not use any other dosing device.

  • mL= milliliter
  • keep dosing cup with product
  • adults and children 12 years and over: 30 mL every 6 hours
  • children under 12 years of age: do not use

  • When using other Day Time or Night Time products, carefully read each label to ensure correct dosing
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 non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
Product Label
CVS Nighttime Cold & Flu
Other Information
  • each 30 mL contains: potasssium 5 mg
  • each 30 mL contains: sodium 19 mL

  • store between 20-25ºC (68-77ºF). Do not refrigerate.

Inactive Ingredients

acesulfame potassium, alcohol, citric acid, D&C yellow #10, FD&C green #3, FD&C yellow #6,, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Questions Or Comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST 

Principal Display Panel

Compare to Vicks® NyQuil™ Cold & Flu active ingredients*

NIGHTTIME

COLD & FLU

Acetaminophen 

Pain Reliever; Fever Reducer

Dextromethorphan HBr

Cough Suppressant

Doxylamine Succinate

Antihistamine

Multi-Symptom Relief 

Headache, Fever, Sore throat, Minor aches & pains, Sneezing, Runny nose, Cough

Alcohol 10%

Ages 12 & Over

FL OZ (mL)

*This product is not manufactured or distributed by The Procter & Gamble Company. Vicks® and NyQuil™ are registered trademarks of the Procter & Gamble Company.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING.

Distributed by:CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

When Using This Product
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives and tranquilizers may increase drowsiness
Stop Use and Ask A Doctor If
  • pain or cough gets worse or lasts more than 7 days

  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present

  • 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: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick 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 30ml)

Acetaminophen 650 mg

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

Ask A Doctor Before Use If You Have
  • liver disease
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema

  • trouble urinating due to an enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are Taking
  • sedatives or tranquilizers
  • the blood thinning drug warfarin

Structured Label Content

Uses

temporarily relieves these common cold/flu symptoms:

  • minor aches and pains
  • headache
  • sore throat
  • fever
  • runny nose and sneezing
  • cough due to minor throat and bronchial irritation
Purposes

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Warnings

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

  • more than 4,000 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 directed (see Overdose warning)

  • do not take more than 4 doses in 24-hours period

  • measure only with dosing cup provided. Do not use any other dosing device.

  • mL= milliliter
  • keep dosing cup with product
  • adults and children 12 years and over: 30 mL every 6 hours
  • children under 12 years of age: do not use

  • When using other Day Time or Night Time products, carefully read each label to ensure correct dosing
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 non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
Product Label
CVS Nighttime Cold & Flu
Other Information (Other information)
  • each 30 mL contains: potasssium 5 mg
  • each 30 mL contains: sodium 19 mL

  • store between 20-25ºC (68-77ºF). Do not refrigerate.

Inactive Ingredients (Inactive ingredients)

acesulfame potassium, alcohol, citric acid, D&C yellow #10, FD&C green #3, FD&C yellow #6,, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Questions Or Comments? (Questions or comments?)

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST 

Principal Display Panel

Compare to Vicks® NyQuil™ Cold & Flu active ingredients*

NIGHTTIME

COLD & FLU

Acetaminophen 

Pain Reliever; Fever Reducer

Dextromethorphan HBr

Cough Suppressant

Doxylamine Succinate

Antihistamine

Multi-Symptom Relief 

Headache, Fever, Sore throat, Minor aches & pains, Sneezing, Runny nose, Cough

Alcohol 10%

Ages 12 & Over

FL OZ (mL)

*This product is not manufactured or distributed by The Procter & Gamble Company. Vicks® and NyQuil™ are registered trademarks of the Procter & Gamble Company.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING.

Distributed by:CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

When Using This Product (When using this product)
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives and tranquilizers may increase drowsiness
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

  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present

  • 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: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick 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 30ml) (Active ingredients (in each 30mL))

Acetaminophen 650 mg

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • liver disease
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema

  • trouble urinating due to an enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are Taking (Ask a doctor or pharmacist before use if you are taking)
  • sedatives or tranquilizers
  • the blood thinning drug warfarin

Advanced Ingredient Data


Raw Label Data

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