Cvs 44-449 Delisted

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (160 mg)

Inactive Ingredients

Citric Acid Monohydrate Crospovidone, Unspecified D&c Red No. 27 Aluminum Lake D&c Red No. 30 Aluminum Lake Dextrose Monohydrate Ethylcellulose, Unspecified Fd&c Blue No. 1 Aluminum Lake Magnesium Stearate Mannitol High Density Polyethylene Stearic Acid Sucralose

Identifiers & Packaging

Pill Appearance

Imprint: 44;449 Shape: round Color: purple Size: 16 mm Score: 2

Marketing Status

OTC MONOGRAPH DRUG Completed Since 2005-01-28 Until 2027-10-31

Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 160 mg

Uses

temporarily relieves minor aches and pains due to:
- headache
- sore throat
- flu
- toothache
- the common cold
temporarily reduces fever

Warnings

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

more than 5 doses in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen

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

this product does not contain directions or complete warnings for adult use
do not give more than directed
chew or crush tablets completely before swallowing; do not swallow tablets whole
repeat dose every 4 hours while symptoms last
do not give more than 5 times in 24 hours
do not give for more than 5 days unless directed by a doctor
find the right dose on chart below. If possible, use weight to dose; otherwise, use age.

Weight (lb)	Age (yr)	Dose (chewable tablets)*
Under 24	Under 2	Ask a doctor
24-35	2-3	1 tablet
36-47	4-5	1 1/2 tablets
48-59	6-8	2 tablets
60-71	9-10	2 1/2 tablets
72-95	11	3 tablets

*or as 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 your child is allergic to acetaminophen or any of the inactive ingredients in this product

Other Information

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

Inactive Ingredients

citric acid, crospovidone, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, FD&C blue #1 aluminum lake, flavors, magnesium stearate, mannitol, polyethylene, stearic acid, sucralose

Questions Or Comments?

1-800-426-9391

Principal Display Panel

♥CVS

Health®

Compare to the

active ingredient in

Children’s Tylenol®^†

Chewable Tablets

Children’s

Pain Relief

ACETAMINOPHEN, 160 mg

Chewable Tablets

Pain reliever, Fever reducer

Ages 2-11

• Aspirin free

• Ibuprofen free

Actual Size

Grape Flavor

24 CHEWABLE TABLETS

Chew or crush tablets completely before swallowing.

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

^†This product is not manufactured or distributed by Johnson & Johnson

Corporation, owner of the registered trademark Children’s Tylenol®.

50844 REV0522A44908

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2022 CVS/pharmacy CVS.com® 1-800-SHOP CVS V-11112

CVS 44-449

When Using This Product

do not exceed recommended dosage.

Stop Use and Ask A Doctor If

pain gets worse or lasts more than 5 days
fever gets worse or lasts more than 3 days
new symptoms occur
redness or swelling is present

These could be signs of a serious condition.

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.

Ask A Doctor Before Use If Your Child Has

liver disease.

Active Ingredient (in Each Chewable Tablet)

Acetaminophen 160 mg

Ask A Doctor Or Pharmacist Before Use If Your Child Is

taking the blood thinning drug warfarin.

Structured Label Content

Uses

temporarily relieves minor aches and pains due to:
- headache
- sore throat
- flu
- toothache
- the common cold
temporarily reduces fever

Purpose

Pain reliever/fever reducer

Warnings

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

more than 5 doses in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen

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

this product does not contain directions or complete warnings for adult use
do not give more than directed
chew or crush tablets completely before swallowing; do not swallow tablets whole
repeat dose every 4 hours while symptoms last
do not give more than 5 times in 24 hours
do not give for more than 5 days unless directed by a doctor
find the right dose on chart below. If possible, use weight to dose; otherwise, use age.

Weight (lb)	Age (yr)	Dose (chewable tablets)*
Under 24	Under 2	Ask a doctor
24-35	2-3	1 tablet
36-47	4-5	1 1/2 tablets
48-59	6-8	2 tablets
60-71	9-10	2 1/2 tablets
72-95	11	3 tablets

*or as 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 your child is allergic to acetaminophen or any of the inactive ingredients in this product

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

citric acid, crospovidone, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, FD&C blue #1 aluminum lake, flavors, magnesium stearate, mannitol, polyethylene, stearic acid, sucralose

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel (Principal display panel)

♥CVS

Health®

Compare to the

active ingredient in

Children’s Tylenol®^†

Chewable Tablets

Children’s

Pain Relief

ACETAMINOPHEN, 160 mg

Chewable Tablets

Pain reliever, Fever reducer

Ages 2-11

• Aspirin free

• Ibuprofen free

Actual Size

Grape Flavor

24 CHEWABLE TABLETS

Chew or crush tablets completely before swallowing.

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

^†This product is not manufactured or distributed by Johnson & Johnson

Corporation, owner of the registered trademark Children’s Tylenol®.

50844 REV0522A44908

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2022 CVS/pharmacy CVS.com® 1-800-SHOP CVS V-11112

CVS 44-449

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)

pain gets worse or lasts more than 5 days
fever gets worse or lasts more than 3 days
new symptoms occur
redness or swelling is present

These could be signs of a serious condition.

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.

Ask A Doctor Before Use If Your Child Has (Ask a doctor before use if your child has)

liver disease.

Active Ingredient (in Each Chewable Tablet) (Active ingredient (in each chewable tablet))

Acetaminophen 160 mg

Ask A Doctor Or Pharmacist Before Use If Your Child Is (Ask a doctor or pharmacist before use if your child is)

taking the blood thinning drug warfarin.

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves minor aches and pains due to: headache sore throat flu toothache the common cold temporarily reduces fever", "Purpose": "Pain reliever/fever reducer", "Warnings": "Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes more than 5 doses in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 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": "this product does not contain directions or complete warnings for adult use do not give more than directed chew or crush tablets completely before swallowing; do not swallow tablets whole repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours do not give for more than 5 days unless directed by a doctor find the right dose on chart below. If possible, use weight to dose; otherwise, use age. Weight (lb) Age (yr) Dose (chewable tablets)* Under 24 Under 2 Ask a doctor 24-35 2-3 1 tablet 36-47 4-5 1 1/2 tablets 48-59 6-8 2 tablets 60-71 9-10 2 1/2 tablets 72-95 11 3 tablets *or as 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 your child is allergic to acetaminophen or any of the inactive ingredients in this product", "Other information": "store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) avoid high humidity see end flap for expiration date and lot number", "Inactive ingredients": "citric acid, crospovidone, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, FD&C blue #1 aluminum lake, flavors, magnesium stearate, mannitol, polyethylene, stearic acid, sucralose", "Questions or comments?": "1-800-426-9391", "Principal display panel": "♥ CVS Health® Compare to the active ingredient in Children’s Tylenol® † Chewable Tablets Children’s Pain Relief ACETAMINOPHEN, 160 mg Chewable Tablets Pain reliever, Fever reducer Ages 2-11 • Aspirin free • Ibuprofen free Actual Size Grape Flavor 24 CHEWABLE TABLETS Chew or crush tablets completely before swallowing. TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING † This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Children’s Tylenol®. 50844 REV0522A44908 Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 © 2022 CVS/pharmacy CVS.com® 1-800-SHOP CVS V-11112 CVS 44-449", "When using this product": "do not exceed recommended dosage.", "Stop use and ask a doctor if": "pain gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present These could be signs of a serious condition.", "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.", "Ask a doctor before use if your child has": "liver disease.", "Active ingredient (in each chewable tablet)": "Acetaminophen 160 mg", "Ask a doctor or pharmacist before use if your child is": "taking the blood thinning drug warfarin."}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information