meijer 44-617 cfs

meijer 44-617 cfs
SPL v3
SPL
SPL Set ID 9be8437c-6053-4ed4-bdd2-97f556b5289e
Route
oral
Published
Effective Date 2025-10-28
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)
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 polyvinyl alcohol, unspecified povidone, unspecified silicon dioxide sodium starch glycolate type a potato stearic acid talc titanium dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 44;617 Shape: oval Color: red Size: 19 mm Score: 1
Marketing Status
otc monograph drug active Since 2024-10-28
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 

Medication Information

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:

  • blisters
  • rash
  • skin reddening

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.

Uses
  • temporarily relieves these common cold and flu symptoms:
    • headache
    • cough
    • nasal congestion
    • sore throat
    • minor aches and pains
  • temporarily reduces fever
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Directions
  • do not take more than directed
  • do not take more than 12 caplets in any 24-hour period
  • adults and children 12 years and over: take 2 caplets every 4 hours
  • children under 12 years: do not use
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
Inactive Ingredients

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

Description

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

Principal Display Panel

meijer®

NDC 79481-6171-9

Cold, Flu &

Sore Throat

ACETAMINOPHEN

DEXTROMETHORPHAN HBr

GUAIFENESIN

PHENYLEPHRINE HCl

PAIN RELIEVER/FEVER REDUCER

COUGH SUPPRESSANT

EXPECTORANT

NASAL DECONGESTANT

Maximum

Strength

Multi-Symptom

Relieves

Headache, Fever, Sore Throat,

Nasal & Chest Congestion

Controls Cough, Thins & Loosens Mucus

Actual Size

20

Caplets

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

  DIST. BY MEIJER

 DISTRIBUTION, INC.

 GRAND RAPIDS, MI 49544

 www.meijer.com

50844   ORG082361709

Meijer 44-617
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
Questions Or Comments?

1-800-426-9391

When Using This Product

do not exceed recommended dosage.

Stop Use and Ask A Doctor If
  • new symptoms occur
  • redness or swelling is present
  • 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
  • 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.

Ask A Doctor Before Use If You Have
  • liver disease
  • diabetes
  • thyroid disease
  • cough that occurs with too much phlegm (mucus)
  • difficulty in urination due to enlargement of the prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • heart disease
  • high blood pressure
Active Ingredients (in Each Caplet)

Acetaminophen 325 mg 

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg 

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin.

Structured Label Content

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:

  • blisters
  • rash
  • skin reddening

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.

Uses
  • temporarily relieves these common cold and flu symptoms:
    • headache
    • cough
    • nasal congestion
    • sore throat
    • minor aches and pains
  • temporarily reduces fever
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Directions
  • do not take more than directed
  • do not take more than 12 caplets in any 24-hour period
  • adults and children 12 years and over: take 2 caplets every 4 hours
  • children under 12 years: do not use
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
Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel (Principal display panel)

meijer®

NDC 79481-6171-9

Cold, Flu &

Sore Throat

ACETAMINOPHEN

DEXTROMETHORPHAN HBr

GUAIFENESIN

PHENYLEPHRINE HCl

PAIN RELIEVER/FEVER REDUCER

COUGH SUPPRESSANT

EXPECTORANT

NASAL DECONGESTANT

Maximum

Strength

Multi-Symptom

Relieves

Headache, Fever, Sore Throat,

Nasal & Chest Congestion

Controls Cough, Thins & Loosens Mucus

Actual Size

20

Caplets

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

  DIST. BY MEIJER

 DISTRIBUTION, INC.

 GRAND RAPIDS, MI 49544

 www.meijer.com

50844   ORG082361709

Meijer 44-617
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
Questions Or Comments? (Questions or comments?)

1-800-426-9391

When Using This Product (When using this product)

do not exceed recommended dosage.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • new symptoms occur
  • redness or swelling is present
  • 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
  • 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.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • liver disease
  • diabetes
  • thyroid disease
  • cough that occurs with too much phlegm (mucus)
  • difficulty in urination due to enlargement of the prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • heart disease
  • high blood pressure
Active Ingredients (in Each Caplet) (Active ingredients (in each caplet))

Acetaminophen 325 mg 

Dextromethorphan HBr 10 mg

Guaifenesin 200 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 the blood thinning drug warfarin.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:06.610441 · Updated: 2026-03-14T23:13:18.140905