Meijer 44-640677-22

Meijer 44-640677-22
SPL v13
SPL
SPL Set ID d07112dd-27df-46cc-b7c3-af8ba7601d06
Route
ORAL
Published
Effective Date 2026-02-09
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
  • 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
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 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number
Questions Or Comments?

1-800-426-9391

Principal Display Panel

meijer®

COMBO PACK 48 TOTAL CAPLETS

COMPARE TO VICKS® DAYQUIL® & NYQUIL® VAPOCOOL®

SEVERE COLD & FLU + CONGESTION

ACTIVE INGREDIENTS*



NDC 41250-840-22



MAXIMUM STRENGTH

Daytime Severe

Cold & Flu



ACETAMINOPHEN


DEXTROMETHORPHAN HBr

GUAIFENESIN

PHENYLEPHRINE HCl



PAIN RELIEVER | FEVER REDUCER

COUGH SUPPRESSANT

EXPECTORANT

NASAL DECONGESTANT



Relieves:

•Headache

•Fever

•Sore Throat

•Minor Aches & Pains

•Nasal/Sinus Congestion

•Sinus Pressure

•Cough

•Chest Congestion



32

Caplets



Actual Size

  MAXIMUM STRENGTH

Nitetime Severe

Cold & Flu

ACETAMINOPHEN

DEXTROMETHORPHAN HBr

DOXYLAMINE SUCCINATE

PHENYLEPHRINE HCl



PAIN RELIEVER | FEVER REDUCER

COUGH SUPPRESSANT

ANTIHISTAMINE

NASAL DECONGESTANT





Relieves:

•Headache

•Fever

•Sore Throat

•Minor Aches & Pains

•Nasal/Sinus Congestion

•Sinus Pressure

•Sneezing

•Runny Nose

•Cough



16

Caplets



Actual Size

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS

OPENED OR IF BLISTER UNIT IS TORN, BROKEN

OR SHOWS ANY SIGNS OF TAMPERING

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

Do Not Take Daytime and Nighttime

Products at the Same Time.

*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 REV0722D64067722

DIST. BY MEIJER

DISTRIBUTION, INC.

GRAND RAPIDS, MI 49544

www.meijer.com

Meijer 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.
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 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.

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)
  • 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
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 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number
Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel

meijer®

COMBO PACK 48 TOTAL CAPLETS

COMPARE TO VICKS® DAYQUIL® & NYQUIL® VAPOCOOL®

SEVERE COLD & FLU + CONGESTION

ACTIVE INGREDIENTS*



NDC 41250-840-22



MAXIMUM STRENGTH

Daytime Severe

Cold & Flu



ACETAMINOPHEN


DEXTROMETHORPHAN HBr

GUAIFENESIN

PHENYLEPHRINE HCl



PAIN RELIEVER | FEVER REDUCER

COUGH SUPPRESSANT

EXPECTORANT

NASAL DECONGESTANT



Relieves:

•Headache

•Fever

•Sore Throat

•Minor Aches & Pains

•Nasal/Sinus Congestion

•Sinus Pressure

•Cough

•Chest Congestion



32

Caplets



Actual Size

  MAXIMUM STRENGTH

Nitetime Severe

Cold & Flu

ACETAMINOPHEN

DEXTROMETHORPHAN HBr

DOXYLAMINE SUCCINATE

PHENYLEPHRINE HCl



PAIN RELIEVER | FEVER REDUCER

COUGH SUPPRESSANT

ANTIHISTAMINE

NASAL DECONGESTANT





Relieves:

•Headache

•Fever

•Sore Throat

•Minor Aches & Pains

•Nasal/Sinus Congestion

•Sinus Pressure

•Sneezing

•Runny Nose

•Cough



16

Caplets



Actual Size

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS

OPENED OR IF BLISTER UNIT IS TORN, BROKEN

OR SHOWS ANY SIGNS OF TAMPERING

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

Do Not Take Daytime and Nighttime

Products at the Same Time.

*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 REV0722D64067722

DIST. BY MEIJER

DISTRIBUTION, INC.

GRAND RAPIDS, MI 49544

www.meijer.com

Meijer 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.
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 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.

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


Raw Label Data

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