Equate 44-692

Equate 44-692
SPL v7
SPL
SPL Set ID f9d1dfd1-527f-491d-9188-14886ac70ced
Route
ORAL
Published
Effective Date 2025-06-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Chlorpheniramine (2 mg)
Inactive Ingredients
Starch, Corn Crospovidone, Unspecified Fd&c Red No. 40 Aluminum Lake Magnesium Stearate 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;692 Shape: round Color: red Size: 19 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-04-14

Description

Acetaminophen 325 mg Chlorpheniramine maleate 2 mg

Purpose

Pain reliever/fever reducer Antihistamine


Medication Information

Purpose

Pain reliever/fever reducer

Antihistamine

Description

Acetaminophen 325 mg Chlorpheniramine maleate 2 mg

Uses
  • temporarily relieves:
    • headache
    • sneezing
    • runny nose
    • minor aches and pains
    • sore throat
  • temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if

  • adult takes more than 4,000 mg of acetaminophen in 24 hours
  • child takes more than 5 doses in 24 hours
  • taken with other drugs containing acetaminophen
  • adult has 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
adults and children 12 years and over 2 tablets every 4 to 6 hours; do not take more than 12 tablets in 24 hours
children 6 to under 12 years 1 tablet every 4 to 6 hours; do not take more than 5 tablets in 24 hours
children under 6 years do not use unless directed by 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 have ever had an allergic reaction to this product or any of its ingredients
  • to make a child sleepy

Other Information
  • 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, magnesium stearate, 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 79903-120-09

Compare to

Coricidin® HBP

Cold & Flu

active

ingredients*

DECONGESTANT-FREE

Cold & Flu HBP

Acetaminophen - Pain reliever/Fever reducer

Chlorpheniramine maleate - Antihistamine

FOR PEOPLE WITH

HIGH BLOOD PRESSURE

Relieves:

• Runny nose

• Sneezing

• Body aches & pains

• Fever, sore throat

Actual Size

20

TABLETS

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS

OPENED OR IF BLISTER UNIT IS TORN, BROKEN

OR SHOWS ANY SIGNS OF TAMPERING

Satisfaction guaranteed – For questions

or comments please call 1-888-287-1915.

DISTRIBUTED BY: Walmart Inc.,

Bentonville, AR 72716

*This product is not manufactured or distributed by

Bayer HealthCare LLC, owner of the registered

trademark Coricidin® HBP Cold & Flu.

50844                                                 REV1020A69209

Equate 44-692
When Using This Product
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • use caution when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children
  • drowsiness may occur
  • avoid alcoholic beverages
Stop Use and Ask A Doctor If
  • pain gets worse or lasts more than 5 days (children 6 to under 12 years) or 10 days (adults)
  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

In case of accidental 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 Tablet)

Acetaminophen 325 mg

Chlorpheniramine maleate 2 mg

Ask A Doctor Before Use If the User Has
  • difficulty in urination due to enlargement of the prostate gland
  • liver disease
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
Ask A Doctor Or Pharmacist Before Use If The user Is
  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin


Structured Label Content

Uses
  • temporarily relieves:
    • headache
    • sneezing
    • runny nose
    • minor aches and pains
    • sore throat
  • temporarily reduces fever

Purpose

Pain reliever/fever reducer

Antihistamine

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if

  • adult takes more than 4,000 mg of acetaminophen in 24 hours
  • child takes more than 5 doses in 24 hours
  • taken with other drugs containing acetaminophen
  • adult has 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
adults and children 12 years and over 2 tablets every 4 to 6 hours; do not take more than 12 tablets in 24 hours
children 6 to under 12 years 1 tablet every 4 to 6 hours; do not take more than 5 tablets in 24 hours
children under 6 years do not use unless directed by 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 have ever had an allergic reaction to this product or any of its ingredients
  • to make a child sleepy

Other Information (Other information)
  • 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, magnesium stearate, 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 79903-120-09

Compare to

Coricidin® HBP

Cold & Flu

active

ingredients*

DECONGESTANT-FREE

Cold & Flu HBP

Acetaminophen - Pain reliever/Fever reducer

Chlorpheniramine maleate - Antihistamine

FOR PEOPLE WITH

HIGH BLOOD PRESSURE

Relieves:

• Runny nose

• Sneezing

• Body aches & pains

• Fever, sore throat

Actual Size

20

TABLETS

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS

OPENED OR IF BLISTER UNIT IS TORN, BROKEN

OR SHOWS ANY SIGNS OF TAMPERING

Satisfaction guaranteed – For questions

or comments please call 1-888-287-1915.

DISTRIBUTED BY: Walmart Inc.,

Bentonville, AR 72716

*This product is not manufactured or distributed by

Bayer HealthCare LLC, owner of the registered

trademark Coricidin® HBP Cold & Flu.

50844                                                 REV1020A69209

Equate 44-692
When Using This Product (When using this product)
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • use caution when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children
  • drowsiness may occur
  • avoid alcoholic beverages
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • pain gets worse or lasts more than 5 days (children 6 to under 12 years) or 10 days (adults)
  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present

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 accidental 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 Tablet) (Active ingredients (in each tablet))

Acetaminophen 325 mg

Chlorpheniramine maleate 2 mg

Ask A Doctor Before Use If the User Has (Ask a doctor before use if the user has)
  • difficulty in urination due to enlargement of the prostate gland
  • liver disease
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
Ask A Doctor Or Pharmacist Before Use If The user Is (Ask a doctor or pharmacist before use if the user is)
  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin


Advanced Ingredient Data


Raw Label Data

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