Walgreen Daytime Nighttime Cold & Flu Drug Facts

Walgreen Daytime Nighttime Cold & Flu Drug Facts
SPL v5
SPL
SPL Set ID 5505217a-9679-4668-bdab-5d4553a47c56
Route
ORAL
Published
Effective Date 2021-02-18
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 (400 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 2021-02-10

Description

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

Purpose

Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant


Medication Information

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

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
Warnings

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

  • more than 4 doses in 24 hours, which is the maximum daily amount for this product
  • 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 – 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

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

citric acid, D&C yellow #10, edetate disodium, FD&C blue #1, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose

Questions Or Comments?

1-866-467-2748

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 at (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.

Package/label Principal Display Panel

VALUE PACK

*Compare to the active ingredients in Vicks® Dayquil® Severe+ VapoCOOL™

DayTime

Cold & Flu

Relief

Acetaminophen- Pain reliever / Fever reducer

Dextromethorphan HBr - Cough supressant

Guaifenesin - Expectorant

Phenylephrine HCl - Nasal decongestant

For Relief of

  • Minor Aches & Pains, Fever
  • Nasal Congestion & Sinus Pressure
  • Cough
  • Chest Congestion

TWO BOTTLES, 12 FL OZ(354 mL)

**Compare to the active ingredients in Vicks® Nyquil® Severe+ VapoCOOL™

NightTime

Cold & Flu

Relief

Acetaminophen- Pain reliever / Fever reducer

Dextromethorphan HBr - Cough supressant

Doxylamine succinate - Antihistamine

Phenylephrine HCl - Nasal decongestant

For Relief of

  • Minor Aches & Pains, Fever
  • Nasal Congestion & Sinus Pressure
  • Sneezing, Runny Nose
  • Cough

Each; TOTAL 24 FL OZ(708 mL)

Active Ingredients (in Each 30 Ml) Day Time

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 mg

Active Ingredients (in Each 30 Ml) – Nighttime

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Doxylamine succinate 12.5 mg

Phenylephrine HCl 10 mg


Structured Label Content

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

Warnings

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

  • more than 4 doses in 24 hours, which is the maximum daily amount for this product
  • 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 – 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

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.
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 #10, edetate disodium, FD&C blue #1, flavor, 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

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 at (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.

Package/label Principal Display Panel (Package/Label Principal Display Panel)

VALUE PACK

*Compare to the active ingredients in Vicks® Dayquil® Severe+ VapoCOOL™

DayTime

Cold & Flu

Relief

Acetaminophen- Pain reliever / Fever reducer

Dextromethorphan HBr - Cough supressant

Guaifenesin - Expectorant

Phenylephrine HCl - Nasal decongestant

For Relief of

  • Minor Aches & Pains, Fever
  • Nasal Congestion & Sinus Pressure
  • Cough
  • Chest Congestion

TWO BOTTLES, 12 FL OZ(354 mL)

**Compare to the active ingredients in Vicks® Nyquil® Severe+ VapoCOOL™

NightTime

Cold & Flu

Relief

Acetaminophen- Pain reliever / Fever reducer

Dextromethorphan HBr - Cough supressant

Doxylamine succinate - Antihistamine

Phenylephrine HCl - Nasal decongestant

For Relief of

  • Minor Aches & Pains, Fever
  • Nasal Congestion & Sinus Pressure
  • Sneezing, Runny Nose
  • Cough

Each; TOTAL 24 FL OZ(708 mL)

Active Ingredients (in Each 30 Ml) Day Time (Active ingredients (in each 30 mL) - Day Time)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 mg

Active Ingredients (in Each 30 Ml) – Nighttime (Active ingredients (in each 30 mL) – NightTime)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Doxylamine succinate 12.5 mg

Phenylephrine HCl 10 mg


Advanced Ingredient Data


Raw Label Data

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