Equate 44-617

Equate 44-617
SPL v3
SPL
SPL Set ID de55a9fd-53a2-4f3e-82b7-cabcbe287d46
Route
ORAL
Published
Effective Date 2025-12-12
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 2023-12-15

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




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.



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


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
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



Questions Or Comments?

1-888-287-1915

Principal Display Panel

equate™

NDC 79903-218-20

Cold & Flu

Acetaminophen - 
Pain Reliever/Fever Reducer

Dextromethorphan HBr - Cough Suppressant

Guaifenesin - Expectorant

Phenylephrine HCl - Nasal Decongestant

MAXIMUM STRENGTH

Relieves:

• Fever

• Cough

• Nasal congestion

• Body pain

• Sore throat

• Chest congestion

• Sinus congestion

• Headache

Ages 12+

Actual Size

20

CAPLETS

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS

OPENED OR IF BLISTER IS TORN, BROKEN

OR SHOWS ANY SIGNS OF TAMPERING

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

Satisfaction Guaranteed

For more information call

1-888-287-1915 or visit

Walmart.com/equate

DISTRIBUTED BY: Walmart Inc.

Bentonville, AR 72716

50844      REV0823A61709

Equate 44-617
When Using This Product

do not exceed recommended dosage.



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
  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • 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.



Active Ingredients (in Each Caplet)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

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


Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin.




Structured Label Content

Uses
  • temporarily relieves these common cold and flu symptoms:
    • nasal congestion
    • sore throat
    • cough
    • headache
    • minor aches and pains
    • sinus congestion and pressure
  • 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

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.



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


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
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



Questions Or Comments? (Questions or comments?)

1-888-287-1915

Principal Display Panel (Principal display panel)

equate™

NDC 79903-218-20

Cold & Flu

Acetaminophen - 
Pain Reliever/Fever Reducer

Dextromethorphan HBr - Cough Suppressant

Guaifenesin - Expectorant

Phenylephrine HCl - Nasal Decongestant

MAXIMUM STRENGTH

Relieves:

• Fever

• Cough

• Nasal congestion

• Body pain

• Sore throat

• Chest congestion

• Sinus congestion

• Headache

Ages 12+

Actual Size

20

CAPLETS

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS

OPENED OR IF BLISTER IS TORN, BROKEN

OR SHOWS ANY SIGNS OF TAMPERING

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

Satisfaction Guaranteed

For more information call

1-888-287-1915 or visit

Walmart.com/equate

DISTRIBUTED BY: Walmart Inc.

Bentonville, AR 72716

50844      REV0823A61709

Equate 44-617
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)
  • nervousness, dizziness, or sleeplessness occur 
  • pain, nasal congestion, or cough gets worse or lasts more than 7 days
  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • 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.



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


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

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