Walgreen Daytime Nighttime Cold & Flu Relief Drug Facts

Walgreen Daytime Nighttime Cold & Flu Relief Drug Facts
SPL v1
SPL
SPL Set ID 2bff414d-543f-4f46-ba84-1da1e64b9239
Route
ORAL
Published
Effective Date 2021-03-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg) Doxylamine (6.25 mg) Phenylephrine (5 mg) Guaifenesin (200 mg)
Inactive Ingredients
Anhydrous Citric Acid D&c Yellow No. 10 Edetate Disodium Fd&c Green No. 3 Fd&c Red No. 40 Glycerin Menthol, Unspecified Form Propylene Glycol Water Sodium Benzoate Sodium Citrate, Unspecified Form Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: brown
Marketing Status
OTC MONOGRAPH FINAL Active Since 2021-02-22

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg Phenylephrine HCl 5 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 325 mg Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg Phenylephrine HCl 5 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
  • 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 6 to under 12 yrs

15mL every 4 hrs

children under 4 to under 6 yrs

do not use unless directed by 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.
  • to make child sleepy
Other Information
  • each 15 mL contains: sodium 9 mg
  • store at room temperature
  • Do not refrigerate
Inactive Ingredients

citric acid, D&C yellow #10, edetate disodium, FD&C Green No 3, FD&C Red No.40, flavors, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

Questions Or Comments?

1-866-467-2748

When Using This Product

do not use more than directed

If Pregnant Or Breast Feeding,

Keep out of reach of children.

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.

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 cold & Flu Honey Flavor

DayTime

Cold & Flu

Relief

Acetaminophen - Pain reliever / Fever reducer

Guaifenesin - Expectorant

Phenylephrine HCl - Nasal decongestant

Dextromethorphan HBr - Cough supressant

  • Headache, Fever, sore Throat, Minor Aches & Pains
  • Chest Congestion Thins & Loosen Mucus
  • Nasal Congestion & Sinus Pressure
  • Cough

Honey Flavor

Naturally and Artificially Flavored

TWO BOTTLES, 12 FL OZ (354 mL)

**Compare to the active ingredients in Vicks® Nyquil™ Severe cold & Flu Honey Flavor

Nighttime

Cold & Flu

Relief

Acetaminophen - Pain reliever / Fever reducer

Phenylephrine HCl - Nasal decongestant

Doxylamine succinate - Antihistamine

Dextromethorphan HBr - Cough supressant

For Relief of

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

Honey Flavor

Naturally and Artificially Flavored

Each; TOTAL 24 FL OZ (708 mL)

Active Ingredients (in Each 15 Ml) Day Time

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Active Ingredients (in Each 15 Ml) – Nighttime

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg

Ask A Doctor Or Pharmacist Before Use If You Are
  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin.

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
  • 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 6 to under 12 yrs

15mL every 4 hrs

children under 4 to under 6 yrs

do not use unless directed by 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.
  • to make child sleepy
Other Information (Other information)
  • each 15 mL contains: sodium 9 mg
  • store at room temperature
  • Do not refrigerate
Inactive Ingredients (Inactive ingredients)

citric acid, D&C yellow #10, edetate disodium, FD&C Green No 3, FD&C Red No.40, flavors, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

Questions Or Comments? (Questions or comments?)

1-866-467-2748

When Using This Product (When using this product)

do not use more than directed

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

Keep out of reach of children.

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.

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 cold & Flu Honey Flavor

DayTime

Cold & Flu

Relief

Acetaminophen - Pain reliever / Fever reducer

Guaifenesin - Expectorant

Phenylephrine HCl - Nasal decongestant

Dextromethorphan HBr - Cough supressant

  • Headache, Fever, sore Throat, Minor Aches & Pains
  • Chest Congestion Thins & Loosen Mucus
  • Nasal Congestion & Sinus Pressure
  • Cough

Honey Flavor

Naturally and Artificially Flavored

TWO BOTTLES, 12 FL OZ (354 mL)

**Compare to the active ingredients in Vicks® Nyquil™ Severe cold & Flu Honey Flavor

Nighttime

Cold & Flu

Relief

Acetaminophen - Pain reliever / Fever reducer

Phenylephrine HCl - Nasal decongestant

Doxylamine succinate - Antihistamine

Dextromethorphan HBr - Cough supressant

For Relief of

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

Honey Flavor

Naturally and Artificially Flavored

Each; TOTAL 24 FL OZ (708 mL)

Active Ingredients (in Each 15 Ml) Day Time (Active ingredients (in each 15 mL) - Day Time)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Active Ingredients (in Each 15 Ml) – Nighttime (Active ingredients (in each 15 mL) – NightTime)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg

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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