Equate 44-617694-09-cold And Flu

Equate 44-617694-09-cold And Flu
SPL v3
SPL
SPL Set ID 26f55169-4b37-4a36-88ee-064d6e962065
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) Diphenhydramine (12.5 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 Croscarmellose Sodium Fd&c Blue No. 1 Aluminum Lake Fd&c Blue No. 2 Aluminum Lake Ferric Oxide Yellow Methacrylic Acid And Ethyl Acrylate Copolymer Sodium Bicarbonate

Identifiers & Packaging

Pill Appearance
Imprint: 44;694 Shape: oval Color: red Color: blue Size: 19 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-12-08

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:
    • headache
    • minor aches and pains
    • nasal congestion
    • cough
    • sore throat
    • sinus congestion and pressure
    • runny nose and sneezing (nighttime only)
    • itching of the nose or throat (nighttime only)
    • itchy, watery eyes due to hay fever (nighttime only)
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (daytime only)
  • controls cough to help you get to sleep
  • temporarily reduces fever
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.
  • with any other product containing diphenhydramine, even one used on skin (nighttime only)
Other Information
  • each caplet contains: sodium 3 mg (daytime only )
  • 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
Purpose (daytime)

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Purpose (nighttime)

Pain reliever/fever reducer

Antihistamine/cough suppressant

Nasal decongestant

Questions Or Comments?

1-888-287-1915

Principal Display Panel

equate

NDC 79903-236-20

DAYTIME

Cold & Flu

Acetaminophen-

Pain Reliever/

Fever Reducer,

Dextromethorphan HBr -

Cough Suppressant

Guaifenesin - Expectorant

Phenylephrine HCl -

Nasal Decongestant

MAXIMUM STRENGTH

• Relieves headache,

body pain, sore throat,

fever, cough, nasal &

chest congestion,

sinus congestion

& pressure

12

Caplets

Actual Size

NIGHTTIME

Cold & Flu

Acetaminophen -

Pain Reliever/

Fever Reducer,

Diphenhydramine HCl -

Antihistamine/

Cough Suppressant

Phenylephrine HCl -

Nasal Decongestant

MAXIMUM STRENGTH

• Relieves headache,

body pain, sore throat,

fever, cough, itchy throat,

nasal congestion,

sneezing, runny nose

8

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

DISTRIBUTED BY: Walmart Inc.,

Bentonville, AR 72716

50844     REV0824A61769409

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

Do not take Daytime and Nighttime

products at the same time.

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 44-617694
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)
  • alcohol, sedatives, and tranquilizers may increase drowsiness (nighttime only)
  • use caution when driving a motor vehicle or operating machinery (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
  • heart disease
  • thyroid disease
  • diabetes
  • liver 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)
  • a breathing problem such as emphysema or chronic bronchitis (nighttime only)
  • glaucoma (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, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

Inactive Ingredients (nighttime Only)

corn starch, croscarmellose sodium, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, iron oxide yellow, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium bicarbonate, stearic acid, talc, titanium dioxide

Active Ingredients (in Each Caplet) (daytime)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Active Ingredients (in Each Caplet) (nighttime)

Acetaminophen 325 mg

Diphenhydramine HCl 12.5 mg

Phenylephrine HCl 5 mg

Ask A Doctor Or Pharmacist Before Use If You Are
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers (nighttime only)

Structured Label Content

Uses
  • temporarily relieves these common cold and flu symptoms:
    • headache
    • minor aches and pains
    • nasal congestion
    • cough
    • sore throat
    • sinus congestion and pressure
    • runny nose and sneezing (nighttime only)
    • itching of the nose or throat (nighttime only)
    • itchy, watery eyes due to hay fever (nighttime only)
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (daytime only)
  • controls cough to help you get to sleep
  • temporarily reduces fever
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.
  • with any other product containing diphenhydramine, even one used on skin (nighttime only)
Other Information (Other information)
  • each caplet contains: sodium 3 mg (daytime only )
  • 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
Purpose (daytime)

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Purpose (nighttime)

Pain reliever/fever reducer

Antihistamine/cough suppressant

Nasal decongestant

Questions Or Comments? (Questions or comments?)

1-888-287-1915

Principal Display Panel (Principal display panel)

equate

NDC 79903-236-20

DAYTIME

Cold & Flu

Acetaminophen-

Pain Reliever/

Fever Reducer,

Dextromethorphan HBr -

Cough Suppressant

Guaifenesin - Expectorant

Phenylephrine HCl -

Nasal Decongestant

MAXIMUM STRENGTH

• Relieves headache,

body pain, sore throat,

fever, cough, nasal &

chest congestion,

sinus congestion

& pressure

12

Caplets

Actual Size

NIGHTTIME

Cold & Flu

Acetaminophen -

Pain Reliever/

Fever Reducer,

Diphenhydramine HCl -

Antihistamine/

Cough Suppressant

Phenylephrine HCl -

Nasal Decongestant

MAXIMUM STRENGTH

• Relieves headache,

body pain, sore throat,

fever, cough, itchy throat,

nasal congestion,

sneezing, runny nose

8

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

DISTRIBUTED BY: Walmart Inc.,

Bentonville, AR 72716

50844     REV0824A61769409

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

Do not take Daytime and Nighttime

products at the same time.

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 44-617694
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)
  • alcohol, sedatives, and tranquilizers may increase drowsiness (nighttime only)
  • use caution when driving a motor vehicle or operating machinery (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)
  • heart disease
  • thyroid disease
  • diabetes
  • liver 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)
  • a breathing problem such as emphysema or chronic bronchitis (nighttime only)
  • glaucoma (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, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

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

corn starch, croscarmellose sodium, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, iron oxide yellow, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium bicarbonate, stearic acid, talc, titanium dioxide

Active Ingredients (in Each Caplet) (daytime) (Active ingredients (in each caplet) (daytime))

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Active Ingredients (in Each Caplet) (nighttime) (Active ingredients (in each caplet) (nighttime))

Acetaminophen 325 mg

Diphenhydramine HCl 12.5 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
  • taking sedatives or tranquilizers (nighttime only)

Advanced Ingredient Data


Raw Label Data

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