Walgreens 44-640677-22

Walgreens 44-640677-22
SPL v16
SPL
SPL Set ID 5fe9f313-d6e7-41f5-abfc-e4c72b708961
Route
ORAL
Published
Effective Date 2025-12-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg) Guaifenesin (200 mg) Phenylephrine (5 mg) Doxylamine (6.25 mg)
Inactive Ingredients
Starch, Corn Crospovidone, Unspecified Fd&c Red No. 40 Aluminum Lake Fd&c Yellow No. 6 Aluminum Lake Magnesium Stearate Maltodextrin Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polysorbate 80 Polyvinyl Alcohol, Unspecified Povidone, Unspecified Silicon Dioxide Sodium Starch Glycolate Type A Potato Stearic Acid Talc Titanium Dioxide Ferrosoferric Oxide D&c Yellow No. 10 Aluminum Lake Fd&c Blue No. 1 Aluminum Lake

Identifiers & Packaging

Pill Appearance
Imprint: 44;677 Shape: oval Color: orange Color: green Size: 19 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-08-01

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 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 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg

Uses
  • temporarily relieves common cold and flu symptoms:
    • minor aches and pains
    • nasal congestion
    • headache
    • fever
    • sore throat
    • sinus congestion and pressure
    • cough due to minor throat and bronchial irritation
    • cough to help you sleep  (Nighttime only)
    • runny nose and sneezing (Nighttime only)
  • reduces swelling of nasal passages
  • temporarily restores freer breathing through the nose
  • promotes nasal and/or sinus drainage
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (Daytime only)
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.

Directions
  • do not take more than directed
  • do not take more than 8 caplets of Daytime and Nighttime products in any 24-hour period
  • adults and children 12 years and over: take 2 caplets with water every 4 hours
  • children under 12 years: ask a doctor
Do Not Use
  • if you have ever had an allergic reaction to this product or any of its ingredients
  • 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 caplet contains: sodium 3 mg
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number
Questions Or Comments?

1-800-426-9391

Principal Display Panel

DAY & NIGHT PACK

Walgreens

WALGREENS

PHARMACIST RECOMMENDED

Compare to the active ingredients in Vicks® DayQuil®

VapoCOOL® SEVERE COLD & FLU + CONGESTION and Vicks®

NyQuil® VapoCOOL® SEVERE COLD & FLU + CONGESTION††

DAYTIME

Severe

Cold & Flu

ACETAMINOPHEN / PAIN RELIEVER / FEVER REDUCER

DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT

GUAIFENESIN / EXPECTORANT

PHENYLEPHRINE HCl / NASAL DECONGESTANT

Maximum Strength

32 CAPLETS

ACTUAL SIZE

NIGHTTIME

Severe

Cold & Flu

ACETAMINOPHEN / PAIN RELIEVER / FEVER REDUCER

DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT

DOXYLAMINE SUCCINATE / ANTIHISTAMINE

PHENYLEPHRINE HCl / NASAL DECONGESTANT

Maximum Strength

16 CAPLETS

ACTUAL SIZE

48 TOTAL CAPLETS

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER

UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

Do Not Take Daytime and

Nighttime Products at the

Same Time.

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

Our pharmacists recommend the Walgreens brand.

We invite you to compare to national brands.

††This product is not manufactured or distributed by

The Procter & Gamble Company, owner of the registered

trademark Vicks® DayQuil® VapoCOOL® SEVERE COLD

& FLU + CONGESTION and Vicks® NyQuil® VapoCOOL®

SEVERE COLD & FLU + CONGESTION.

50844                       REV0722B64067722

NDC 0363-6406-22

DISTRIBUTED BY: WALGREEN CO.

DEERFIELD, IL 60015

Walgreens

100 % SATISFACTION

GUARANTEED

walgreens.com

©2024 Walgreen Co.

Walgreens 44-640677
When Using This Product
  • do not exceed recommended dosage
  • excitability may occur, especially in children (Nighttime only)
  • marked drowsiness may occur (Nighttime only)
  • avoid alcoholic beverages (Nighttime only)
  • be careful when driving a motor vehicle or operating machinery (Nighttime only)
  • alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only)
Stop Use and Ask A Doctor If
  • nervousness, dizziness, or sleeplessness occur
  • 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.
Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Do not take DAYTIME and NIGHTTIME products at the same time.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Ask A Doctor Before Use If You Have
  • liver disease
  • diabetes
  • high blood pressure
  • glaucoma (Nighttime only)
  • thyroid disease
  • heart disease
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema (Daytime only)
  • difficulty in urination due to enlargement of the prostate gland
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema (Nighttime only)
Inactive Ingredients (daytime Only)

corn starch, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

Inactive Ingredients (nighttime Only)

black iron oxide, corn starch, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

Ask A Doctor Or Pharmacist Before Use If You Are
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers (Nighttime only)
Active Ingredients (in Each Caplet) (daytime Severe Cold & Flu)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Active Ingredients (in Each Caplet) (nighttime Severe Cold & Flu)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg


Structured Label Content

Uses
  • temporarily relieves common cold and flu symptoms:
    • minor aches and pains
    • nasal congestion
    • headache
    • fever
    • sore throat
    • sinus congestion and pressure
    • cough due to minor throat and bronchial irritation
    • cough to help you sleep  (Nighttime only)
    • runny nose and sneezing (Nighttime only)
  • reduces swelling of nasal passages
  • temporarily restores freer breathing through the nose
  • promotes nasal and/or sinus drainage
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (Daytime only)
Purpose

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 4,000 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.

Directions
  • do not take more than directed
  • do not take more than 8 caplets of Daytime and Nighttime products in any 24-hour period
  • adults and children 12 years and over: take 2 caplets with water every 4 hours
  • children under 12 years: ask a doctor
Do Not Use (Do not use)
  • if you have ever had an allergic reaction to this product or any of its ingredients
  • 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 caplet contains: sodium 3 mg
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number
Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel

DAY & NIGHT PACK

Walgreens

WALGREENS

PHARMACIST RECOMMENDED

Compare to the active ingredients in Vicks® DayQuil®

VapoCOOL® SEVERE COLD & FLU + CONGESTION and Vicks®

NyQuil® VapoCOOL® SEVERE COLD & FLU + CONGESTION††

DAYTIME

Severe

Cold & Flu

ACETAMINOPHEN / PAIN RELIEVER / FEVER REDUCER

DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT

GUAIFENESIN / EXPECTORANT

PHENYLEPHRINE HCl / NASAL DECONGESTANT

Maximum Strength

32 CAPLETS

ACTUAL SIZE

NIGHTTIME

Severe

Cold & Flu

ACETAMINOPHEN / PAIN RELIEVER / FEVER REDUCER

DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT

DOXYLAMINE SUCCINATE / ANTIHISTAMINE

PHENYLEPHRINE HCl / NASAL DECONGESTANT

Maximum Strength

16 CAPLETS

ACTUAL SIZE

48 TOTAL CAPLETS

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER

UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

Do Not Take Daytime and

Nighttime Products at the

Same Time.

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

Our pharmacists recommend the Walgreens brand.

We invite you to compare to national brands.

††This product is not manufactured or distributed by

The Procter & Gamble Company, owner of the registered

trademark Vicks® DayQuil® VapoCOOL® SEVERE COLD

& FLU + CONGESTION and Vicks® NyQuil® VapoCOOL®

SEVERE COLD & FLU + CONGESTION.

50844                       REV0722B64067722

NDC 0363-6406-22

DISTRIBUTED BY: WALGREEN CO.

DEERFIELD, IL 60015

Walgreens

100 % SATISFACTION

GUARANTEED

walgreens.com

©2024 Walgreen Co.

Walgreens 44-640677
When Using This Product (When using this product)
  • do not exceed recommended dosage
  • excitability may occur, especially in children (Nighttime only)
  • marked drowsiness may occur (Nighttime only)
  • avoid alcoholic beverages (Nighttime only)
  • be careful when driving a motor vehicle or operating machinery (Nighttime only)
  • alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only)
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • nervousness, dizziness, or sleeplessness occur
  • 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.
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 right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Do not take DAYTIME and NIGHTTIME products at the same time.

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

ask a health professional before use.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • liver disease
  • diabetes
  • high blood pressure
  • glaucoma (Nighttime only)
  • thyroid disease
  • heart disease
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema (Daytime only)
  • difficulty in urination due to enlargement of the prostate gland
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema (Nighttime only)
Inactive Ingredients (daytime Only) (Inactive ingredients (Daytime only))

corn starch, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

Inactive Ingredients (nighttime Only) (Inactive ingredients (Nighttime only))

black iron oxide, corn starch, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

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
  • taking sedatives or tranquilizers (Nighttime only)
Active Ingredients (in Each Caplet) (daytime Severe Cold & Flu) (Active ingredients (in each caplet) (Daytime severe cold & flu))

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Active Ingredients (in Each Caplet) (nighttime Severe Cold & Flu) (Active ingredients (in each caplet) (Nighttime severe cold & flu))

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg


Advanced Ingredient Data


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