Equate 44-059

Equate 44-059
SPL v5
SPL
SPL Set ID 52a398eb-e593-458b-9c42-6f653ca391be
Route
ORAL
Published
Effective Date 2026-02-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (650 mg) Dextromethorphan (20 mg) Guaifenesin (400 mg) Phenylephrine (10 mg)
Inactive Ingredients
Anhydrous Citric Acid D&c Yellow No. 10 Fd&c Blue No. 1 Glycerin Polyethylene Glycol 400 Propylene Glycol Water Sodium Benzoate Sodium Chloride Trisodium Citrate Dihydrate Saccharin Sodium Sorbitol Sucralose

Identifiers & Packaging

Pill Appearance
Color: green
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-08-15

Description

Acetaminophen 650 mg Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCl 10 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 650 mg Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCl 10 mg

Uses
  • temporarily relieves common cold and flu symptoms:
    • sore throat
    • nasal congestion
    • minor aches and pains
    • headache
    • sinus congestion and pressure
    • cough due to minor throat and bronchial irritation
  • temporarily reduces fever
  • reduces swelling of nasal passages
  • temporarily restores freer breathing through the nose
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • promotes nasal and/or sinus drainage
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
  • mL = milliliter
  • only use the dose cup provided
  • do not exceed 4 doses per 24 hours
  • adults and children 12 years and over: 30 mL 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 30 mL contains: sodium 11 mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • use by expiration date on package
Inactive Ingredients

anhydrous citric acid, D&C yellow #10, FD&C blue #1, flavors, glycerin, polyethylene glycol 400, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sodium saccharin, sorbitol, sucralose

Questions Or Comments?

1-888-287-1915

Principal Display Panel

equate

NDC 79903-190-12

DAYTIME

SEVERE

VAPOR CHILLING

Cold & Flu

+ Congestion

• Acetaminophen -

  
Pain Reliever/Fever Reducer

• Dextromethorphan HBr -

  Cough Suppressant

• Guaifenesin - Expectorant

• Phenylephrine HCl -

  Nasal Decongestant

Relieves:

• Headache, fever, sore throat, minor aches & pains

• Chest congestion, cough

• Nasal congestion, sinus pressure

• Thins & loosens mucus

For Ages 12+

12 FL OZ (355 mL) 

F-059

REV A

DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

50844    REV0623A05902

B-059 REV A

Satisfaction guaranteed - Or we'll replace it or

give you your money back. For questions or 

comments or to report an undesired reaction

or side effect, please call 1-888-287-1915.

Equate 44-059
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
  • 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.

Active Ingredients (in Each 30 Ml)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 mg

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

taking the blood thinning drug warfarin.


Structured Label Content

Uses
  • temporarily relieves common cold and flu symptoms:
    • sore throat
    • nasal congestion
    • minor aches and pains
    • headache
    • sinus congestion and pressure
    • cough due to minor throat and bronchial irritation
  • temporarily reduces fever
  • reduces swelling of nasal passages
  • temporarily restores freer breathing through the nose
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • promotes nasal and/or sinus drainage
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
  • mL = milliliter
  • only use the dose cup provided
  • do not exceed 4 doses per 24 hours
  • adults and children 12 years and over: 30 mL 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 30 mL contains: sodium 11 mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • use by expiration date on package
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, D&C yellow #10, FD&C blue #1, flavors, glycerin, polyethylene glycol 400, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sodium saccharin, sorbitol, sucralose

Questions Or Comments? (Questions or comments?)

1-888-287-1915

Principal Display Panel (Principal display panel)

equate

NDC 79903-190-12

DAYTIME

SEVERE

VAPOR CHILLING

Cold & Flu

+ Congestion

• Acetaminophen -

  
Pain Reliever/Fever Reducer

• Dextromethorphan HBr -

  Cough Suppressant

• Guaifenesin - Expectorant

• Phenylephrine HCl -

  Nasal Decongestant

Relieves:

• Headache, fever, sore throat, minor aches & pains

• Chest congestion, cough

• Nasal congestion, sinus pressure

• Thins & loosens mucus

For Ages 12+

12 FL OZ (355 mL) 

F-059

REV A

DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

50844    REV0623A05902

B-059 REV A

Satisfaction guaranteed - Or we'll replace it or

give you your money back. For questions or 

comments or to report an undesired reaction

or side effect, please call 1-888-287-1915.

Equate 44-059
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
  • 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.

Active Ingredients (in Each 30 Ml) (Active ingredients (in each 30 mL))

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 mg

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


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Raw Label Data

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