cvs pharmacy, inc. daytime severe nighttime severe drug facts

cvs pharmacy, inc. daytime severe nighttime severe drug facts
SPL v6
SPL
SPL Set ID 1ec3fc79-4f38-439f-99be-646b82231aa5
Route
oral
Published
Effective Date 2025-10-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
acetaminophen (650 mg) dextromethorphan (20 mg) doxylamine (12.5 mg) phenylephrine (10 mg) guaifenesin (325 mg)
Inactive Ingredients
anhydrous citric acid edetate disodium fd&c blue no. 1 fd&c red no. 40 glycerin propylene glycol water saccharin sodium sodium benzoate sodium chloride sodium citrate, unspecified form sorbitol solution sucralose xanthan gum butylated hydroxyanisole fd&c yellow no. 6 menthol, unspecified form sodium phosphate, monobasic, unspecified form polyethylene glycol, unspecified sucrose

Identifiers & Packaging

Pill Appearance
Color: red Color: orange
Marketing Status
otc monograph drug active Since 2013-12-27

Purpose

Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant

Description

Acetaminophen 650 mg Dextromethorphan HBr 20 mg Doxylamine succinate 12.5 mg Phenylephrine HCl 10 mg


Medication Information

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.

Uses

temporarily relieves common cold/flu symptoms:

  • nasal congestion
  • sinus congestion and pressure
  • minor aches and pains
  • headache
  • fever
  • sore throat
  • runny nose and sneezing
  • cough due to minor throat and bronchial irritation
  • cough to help you sleep
  • reduces swelling of nasal passages
  • promotes nasal and/or sinus drainage
  • temporarily restores freer breathing through the nose
Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Directions
  • take only as directed - see Overdose warning
  • only use the dose cup provided
  • do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over

30 mL every 4 hrs

children 4 to under 12 yrs

ask a doctor

children under 4 yrs

do not use

Other Information
  • each 30 mL contains: sodium 41 mg
  • store at 20-25°C (68-77°F)
Inactive Ingredients

anhydrous citric acid, edetate disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution, sucralose, xanthan gum

Description

Acetaminophen 650 mg Dextromethorphan HBr 20 mg Doxylamine succinate 12.5 mg Phenylephrine HCl 10 mg

Do Not Use
  • 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.
  • if you have ever had an allergic reaction to this product or any of its ingredients
Daytime Severe

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Nighttime Severe

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Doxylamine succinate 12.5 mg

Phenylephrine HCl 10 mg

Questions Or Comments?

1-800-719-9260

When Using This Product
  • do not use more than directed
  • 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
  • you get nervous, dizzy or sleepless
  • pain, nasal congestion, 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). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Principal Display Panel Daytime

COMBO PACK

CVS Health®

CVS Health®

Compare to the active ingredients in Vicks® DayQuil® Severe

Non-Drowsy

Daytime Severe

ACETAMINOPHEN – Pain reliever; Fever reducer

DEXTROMETHORPHAN HBr – Cough suppressant

GUAIFENESIN – Expectorant

PHENYLEPHRINE HCl – Nasal decongestant

Relieves: Aches, Fever, Sore throat, Cough, Chest congestion, Nasal congestion

COLD & FLU

ALCOHOL & ANTIHISTAMINE FREE

TOTAL 24 FL OZ (1.5 pt) (710 mL)

CVS Health®

Compare to the active ingredients in Vicks® NyQuil® Severe

MAXIMUM STRENGTH

Nighttime Severe

ACETAMINOPHEN – Pain reliever; Fever reducer

DEXTROMETHORPHAN HBr – Cough suppressant

DOXYLAMINE SUCCINATE – Antihistamine

PHENYLEPHRINE HCl – Nasal decongestant

Relieves: Aches, Fever, Sore throat, Cough, Sneezing, Runny nose, Nasal & Sinus congestion, Sinus pressure

COLD & FLU

Berry Flavor

ALCOHOL FREE

TWO 12 FL OZ (355 mL) UNITS

Ask A Doctor Before Use If You Have
  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • a sodium-restricted diet
Ask A Doctor Or Pharmacist Before Use If You Are
  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

Structured Label Content

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.

Uses

temporarily relieves common cold/flu symptoms:

  • nasal congestion
  • sinus congestion and pressure
  • minor aches and pains
  • headache
  • fever
  • sore throat
  • runny nose and sneezing
  • cough due to minor throat and bronchial irritation
  • cough to help you sleep
  • reduces swelling of nasal passages
  • promotes nasal and/or sinus drainage
  • temporarily restores freer breathing through the nose
Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Directions
  • take only as directed - see Overdose warning
  • only use the dose cup provided
  • do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over

30 mL every 4 hrs

children 4 to under 12 yrs

ask a doctor

children under 4 yrs

do not use

Other Information (Other information)
  • each 30 mL contains: sodium 41 mg
  • store at 20-25°C (68-77°F)
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, edetate disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution, sucralose, xanthan gum

Do Not Use (Do not use)
  • 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.
  • if you have ever had an allergic reaction to this product or any of its ingredients
Daytime Severe

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Nighttime Severe

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Doxylamine succinate 12.5 mg

Phenylephrine HCl 10 mg

Questions Or Comments? (Questions or comments?)

1-800-719-9260

When Using This Product (When using this product)
  • do not use more than directed
  • 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)
  • you get nervous, dizzy or sleepless
  • pain, nasal congestion, 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). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Principal Display Panel Daytime (Principal Display Panel - Daytime)

COMBO PACK

CVS Health®

CVS Health®

Compare to the active ingredients in Vicks® DayQuil® Severe

Non-Drowsy

Daytime Severe

ACETAMINOPHEN – Pain reliever; Fever reducer

DEXTROMETHORPHAN HBr – Cough suppressant

GUAIFENESIN – Expectorant

PHENYLEPHRINE HCl – Nasal decongestant

Relieves: Aches, Fever, Sore throat, Cough, Chest congestion, Nasal congestion

COLD & FLU

ALCOHOL & ANTIHISTAMINE FREE

TOTAL 24 FL OZ (1.5 pt) (710 mL)

CVS Health®

Compare to the active ingredients in Vicks® NyQuil® Severe

MAXIMUM STRENGTH

Nighttime Severe

ACETAMINOPHEN – Pain reliever; Fever reducer

DEXTROMETHORPHAN HBr – Cough suppressant

DOXYLAMINE SUCCINATE – Antihistamine

PHENYLEPHRINE HCl – Nasal decongestant

Relieves: Aches, Fever, Sore throat, Cough, Sneezing, Runny nose, Nasal & Sinus congestion, Sinus pressure

COLD & FLU

Berry Flavor

ALCOHOL FREE

TWO 12 FL OZ (355 mL) UNITS

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
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • a sodium-restricted diet
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

Advanced Ingredient Data


Raw Label Data

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