Walgreens Daytime Severe Cooling Cold And Flu Relief

Walgreens Daytime Severe Cooling Cold And Flu Relief
SPL v6
SPL
SPL Set ID bfc58cd5-9815-43af-895d-ec6cbd10937e
Route
ORAL
Published
Effective Date 2025-11-26
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 D&c Yellow No. 10 Edetate Disodium Fd&c Blue No. 1 Glycerin Propyl Gallate Propylene Glycol Water Sodium Benzoate Sodium Chloride Sodium Citrate, Unspecified Form Sorbitol Sucralose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-02-02

Description

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

Uses
  • temporarily relieves common cold/flu symptoms:
    • nasal congestion
    • sinus congestion & pressure
    • cough due to minor throat and bronchial irritation
    • minor aches and pains
    • headache
    • fever
    • sore throat
    • reduce swelling of nasal passages
    • temporarily restores freer breathing through the nose
    • promotes nasal and/or sinus drainage
  • help loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make cough 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 doses in 24 hrs which is maximum daily amount for this product
  • taken 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
  • take only as directed
  • only use the dose cup provided
  • do not exceed 4 doses per 24 hours

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

Do Not Use
  • 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.
  • 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. 
Other Information
  • each 30 mL contains: sodium 81 mg 
  • store at room temperature. Do not refrigerate
Inactive Ingredients

citric acid, D&C Yellow No. 10, disodium edetate, FD&C Blue No. 1, flavors, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose

Questions Or Comments?

1-866-467-2748

Principal Display Panel

Compare tothe active ingredients in VICKS® Dayquil™ Severe+ VapoCOOL™ *

NDC 0363-7270-12

Day Time

Cold & Flu Relief 

Acetaminophen- Pain Reliever/Fever Reducer

Dextromethorphan HBr - Cough Suppressant

Phenylephrine HCI- Nasal decongestant

For Relieves of

Minor Aches & Pains, Fever

Nasal congestion & Sinus Pressure

Cough

Chest congestion

12 FL OZ (354 mL)

DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN

DISTRIBUTED BY

*This product.is not manufactured or distributed by Procter & Gamble, distributer of Vicks® Dayquil™ Severe+ VapoCOOL™.

When Using This Product,

do not use more than directed.

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 a 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.

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 30 Ml)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 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, or emphysema
  • a sodium-restricted diet
Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin.


Structured Label Content

Uses
  • temporarily relieves common cold/flu symptoms:
    • nasal congestion
    • sinus congestion & pressure
    • cough due to minor throat and bronchial irritation
    • minor aches and pains
    • headache
    • fever
    • sore throat
    • reduce swelling of nasal passages
    • temporarily restores freer breathing through the nose
    • promotes nasal and/or sinus drainage
  • help loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make cough 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 doses in 24 hrs which is maximum daily amount for this product
  • taken 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
  • take only as directed
  • only use the dose cup provided
  • do not exceed 4 doses per 24 hours

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

Do Not Use (Do not use)
  • 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.
  • 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. 
Other Information (Other information)
  • each 30 mL contains: sodium 81 mg 
  • store at room temperature. Do not refrigerate
Inactive Ingredients (Inactive ingredients)

citric acid, D&C Yellow No. 10, disodium edetate, FD&C Blue No. 1, flavors, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose

Questions Or Comments? (Questions or comments?)

1-866-467-2748

Principal Display Panel

Compare tothe active ingredients in VICKS® Dayquil™ Severe+ VapoCOOL™ *

NDC 0363-7270-12

Day Time

Cold & Flu Relief 

Acetaminophen- Pain Reliever/Fever Reducer

Dextromethorphan HBr - Cough Suppressant

Phenylephrine HCI- Nasal decongestant

For Relieves of

Minor Aches & Pains, Fever

Nasal congestion & Sinus Pressure

Cough

Chest congestion

12 FL OZ (354 mL)

DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN

DISTRIBUTED BY

*This product.is not manufactured or distributed by Procter & Gamble, distributer of Vicks® Dayquil™ Severe+ VapoCOOL™.

When Using This Product, (When using this product,)

do not use more than directed.

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 a 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.)

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 30 Ml) (Active ingredients (in each 30 mL))

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 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, 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 the blood thinning drug warfarin.


Advanced Ingredient Data


Raw Label Data

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