0546-cvs - DailyMed Details

0546-cvs

SPL v5

SPL

SPL Set ID 6dea9e11-ff99-63c7-e053-2a91aa0a5b54

Route

oral

Published

Effective Date 2025-06-11

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

acetaminophen (500 mg)

Inactive Ingredients

starch, pregelatinized corn stearic acid povidone sodium starch glycolate type a potato

Identifiers & Packaging

Pill Appearance

Imprint: CPC;546 Shape: round Color: white Size: 12 mm Score: 2

Marketing Status

otc monograph drug active Since 2018-08-06

Purpose

Pain reliever/fever reducer

Description

Active ingredient (in each tablet) Acetaminophen 500 mg

Medication Information

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.

Uses

temporarily relieves minor aches and pains due to:
headache
the common cold
backache
minor pain of arthritis
toothache
muscular aches
premenstrual and menstrual cramps
temporarily reduces fever

Purpose

Pain reliever/fever reducer

Directions

■ do not take more than directed

■ adults and children 12 years and over:

■ take 2 tablets every 6 hours while symptoms last

■ do not take more than 6 tablets in 24 hours, unless directed by a doctor

■ do not take for more than 10 days unless directed by a doctor

■ children under 12 years: ask a doctor

Other Information

■ store in a dry place at 15°-30°C (59°-86°F)

■ see end flap for expiration date and lot number

Inactive Ingredients

povidone, pregelatinized starch, sodium starch glycolate and stearic acid

Description

Active ingredient (in each tablet) Acetaminophen 500 mg

Section 34088-5

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical

attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 42229-5

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION

*CVS is not affiliated with the owner of the registered trademark Tylenol® Extra Strength.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

1-800-SHOP CVS V-34571

Section 51945-4

CVS

NDC 69842-465-12

Extra Strength

ACETAMINOPHEN

Pain Reliever, Fever Reducer, 500 mg

Compare to Tylenol® Extra Strength active ingredient*

100 TABLETS

Contains No Aspirin

For Adults

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 allergic to acetaminophen or any of the inactive ingredients in this product.

Drug Facts

Active ingredient (in each tablet)

Acetaminophen 500 mg

Questions Or Comments?

1-800-231-4670

Stop Use and Ask A Doctor If

■ pain gets worse or lasts more than 10 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

If Pregnant Or Breast Feeding,

ask a health professional before use.

Ask A Doctor Before Use If You Have

liver disease

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin

Structured Label Content

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.

Uses

temporarily relieves minor aches and pains due to:
headache
the common cold
backache
minor pain of arthritis
toothache
muscular aches
premenstrual and menstrual cramps
temporarily reduces fever

Purpose

Pain reliever/fever reducer

Directions

■ do not take more than directed

■ adults and children 12 years and over:

■ take 2 tablets every 6 hours while symptoms last

■ do not take more than 6 tablets in 24 hours, unless directed by a doctor

■ do not take for more than 10 days unless directed by a doctor

■ children under 12 years: ask a doctor

Other Information (Other information)

■ store in a dry place at 15°-30°C (59°-86°F)

■ see end flap for expiration date and lot number

Inactive Ingredients (Inactive ingredients)

povidone, pregelatinized starch, sodium starch glycolate and stearic acid

Section 34088-5 (34088-5)

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical

attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 42229-5 (42229-5)

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION

*CVS is not affiliated with the owner of the registered trademark Tylenol® Extra Strength.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

1-800-SHOP CVS V-34571

Section 51945-4 (51945-4)

CVS

NDC 69842-465-12

Extra Strength

ACETAMINOPHEN

Pain Reliever, Fever Reducer, 500 mg

Compare to Tylenol® Extra Strength active ingredient*

100 TABLETS

Contains No Aspirin

For Adults

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 allergic to acetaminophen or any of the inactive ingredients in this product.

Drug Facts

Active ingredient (in each tablet)

Acetaminophen 500 mg

Questions Or Comments? (Questions or comments?)

1-800-231-4670

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

■ pain gets worse or lasts more than 10 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

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

liver 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

Advanced Ingredient Data

[{"name": "STARCH, PREGELATINIZED CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "500", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "POVIDONE", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A POTATO", "unii": "5856J3G2A2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves minor aches and pains due to: headache the common cold backache minor pain of arthritis toothache muscular aches premenstrual and menstrual cramps temporarily reduces fever", "34088-5": "In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.", "42229-5": "TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION *CVS is not affiliated with the owner of the registered trademark Tylenol® Extra Strength. Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895 © 2025 CVS/pharmacy CVS.com® 1-800-SHOP CVS V-34571", "51945-4": "CVS NDC 69842-465-12 Extra Strength ACETAMINOPHEN Pain Reliever, Fever Reducer, 500 mg Compare to Tylenol® Extra Strength active ingredient* 100 TABLETS Contains No Aspirin For Adults", "Purpose": "Pain reliever/fever reducer", "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.", "Directions": "■ do not take more than directed ■ adults and children 12 years and over: ■ take 2 tablets every 6 hours while symptoms last ■ do not take more than 6 tablets in 24 hours, unless directed by a doctor ■ do not take for more than 10 days unless directed by a doctor ■ children under 12 years: ask 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 are allergic to acetaminophen or any of the inactive ingredients in this product.", "Drug Facts": "Active ingredient (in each tablet) Acetaminophen 500 mg", "Other information": "■ store in a dry place at 15°-30°C (59°-86°F) ■ see end flap for expiration date and lot number", "Inactive ingredients": "povidone, pregelatinized starch, sodium starch glycolate and stearic acid", "Questions or comments?": "1-800-231-4670", "Stop use and ask a doctor if": "■ pain gets worse or lasts more than 10 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", "If pregnant or breast-feeding,": "ask a health professional before use.", "Ask a doctor before use if you have": "liver disease", "Ask a doctor or pharmacist before use if you are": "taking the blood thinning drug warfarin"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:17.930351 · Updated: 2026-03-14T23:08:59.288880