Cvs 44-692 - DailyMed Details

Cvs 44-692

SPL v10

SPL

SPL Set ID 06756130-1608-4ae6-9772-95a4549853a1

Route

ORAL

Published

Effective Date 2025-07-30

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 2017-07-16

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
see end flap for expiration date and lot number
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

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?

1-800-426-9391

Principal Display Panel

CVS _™

NDC 69842-692-09

actual size

COLD &

FLU HBP

Acetaminophen

Pain Reliever, Fever Reducer

Chlorpheniramine Maleate

Antihistamine

Compare to Coricidin^® HBP Cold

& Flu active ingredients*

Relieves: Runny nose, Sneezing,

Body aches & pains, Fever, Sore throat

20 TABLETS

For people with

HIGH BLOOD PRESSURE

TAMPER EVIDENT: DO NOT USE IF

PACKAGE IS OPENED OR IF BLISTER

UNIT IS TORN, BROKEN OR SHOWS

ANY SIGNS OF TAMPERING

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2025 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

V-19849

♥︎ 100% money back

guaranteed.

CVS.com/returnpolicy

*This product is not manufactured or distributed

by Bayer HealthCare LLC, owner of the registered

trademark Coricidin^® HBP Cold & Flu.

50844 ORG102069209

CVS 44-692

When Using This Product

excitability may occur, especially in children
drowsiness may occur
alcohol, sedatives, and tranquilizers may increase drowsiness
avoid alcoholic beverages
use caution when driving a motor vehicle or operating machinery

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
a breathing problem such as emphysema or chronic bronchitis
glaucoma

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
see end flap for expiration date and lot number
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

Inactive Ingredients (Inactive ingredients)

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel

CVS _™

NDC 69842-692-09

actual size

COLD &

FLU HBP

Acetaminophen

Pain Reliever, Fever Reducer

Chlorpheniramine Maleate

Antihistamine

Compare to Coricidin^® HBP Cold

& Flu active ingredients*

Relieves: Runny nose, Sneezing,

Body aches & pains, Fever, Sore throat

20 TABLETS

For people with

HIGH BLOOD PRESSURE

TAMPER EVIDENT: DO NOT USE IF

PACKAGE IS OPENED OR IF BLISTER

UNIT IS TORN, BROKEN OR SHOWS

ANY SIGNS OF TAMPERING

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2025 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

V-19849

♥︎ 100% money back

guaranteed.

CVS.com/returnpolicy

*This product is not manufactured or distributed

by Bayer HealthCare LLC, owner of the registered

trademark Coricidin^® HBP Cold & Flu.

50844 ORG102069209

CVS 44-692

When Using This Product (When using this product)

excitability may occur, especially in children
drowsiness may occur
alcohol, sedatives, and tranquilizers may increase drowsiness
avoid alcoholic beverages
use caution when driving a motor vehicle or operating machinery

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.)

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
a breathing problem such as emphysema or chronic bronchitis
glaucoma

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

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Raw Label Data

All Sections (JSON)

{"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": "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 see end flap for expiration date and lot number store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)", "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?": "1-800-426-9391", "Principal Display Panel": "CVS ™ NDC 69842-692-09 actual size COLD & FLU HBP Acetaminophen Pain Reliever, Fever Reducer Chlorpheniramine Maleate Antihistamine Compare to Coricidin ® HBP Cold & Flu active ingredients* Relieves: Runny nose, Sneezing, Body aches & pains, Fever, Sore throat 20 TABLETS For people with HIGH BLOOD PRESSURE TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 © 2025 CVS/pharmacy CVS.com® 1-800-SHOP CVS V-19849 ♥︎ 100% money back guaranteed. CVS.com/returnpolicy *This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Coricidin ® HBP Cold & Flu. 50844 ORG102069209 CVS 44-692", "When using this product": "excitability may occur, especially in children drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery", "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 a breathing problem such as emphysema or chronic bronchitis glaucoma", "Ask a doctor or pharmacist before use if the user is": "taking sedatives or tranquilizers taking the blood thinning drug warfarin"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:38.841619 · Updated: 2026-03-14T23:09:33.254922