1003-hyv-2025-1120

SPL v2

SPL

SPL Set ID 4227a2cc-69fa-869d-e063-6294a90a1d41

Route

oral

Published

Effective Date 2025-11-20

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

acetaminophen (500 mg)

Inactive Ingredients

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

Identifiers & Packaging

Pill Appearance

Imprint: M2A4;57344 Shape: round Color: white Size: 12 mm Score: 1

Marketing Status

otc monograph drug active Since 2025-11-20

Purpose

Pain reliever/fever reducer

Description

Drug Facts

Medication Information

Active Ingredient

Acetaminophen 500 mg

Uses

temporarily relieves minor aches and pains due to:
- the common cold
- headache
- 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 (see overdose warning)

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 use for more than 10 days unless directed by a doctor
children under 12 years	ask a doctor

Other Information

store between 20-25°C (68-77°F)
retain carton for complete product information

Inactive Ingredients

povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Description

Drug Facts

Principal Display Panel

HyVee®

NDC 42507-103-04

*Compare to the Active Ingredient in Tylenol® Extra Strength

Extra Strength

Pain Relief

Acetaminophen, 500 mg

Pain Reliever / Fever Reducer

For Adults

Actual Size

100 TABLETS

Section 42229-5

Drug Facts

Section 50568-5

Ask a doctor or pharmacist before use if you aretaking the blood thinning drug warfarin

Section 50569-3

Ask a doctor before use if you haveliver disease.

Section 53414-9

If pregnant or breast-feeding,ask a health professional before 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

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.

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

Overdose Warning

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Questions Or Comments?

1-844-705-4384

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.

Structured Label Content

Active Ingredient (Active ingredient (in each tablet))

Acetaminophen 500 mg

Uses

temporarily relieves minor aches and pains due to:
- the common cold
- headache
- 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 (see overdose warning)

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 use for more than 10 days unless directed by a doctor
children under 12 years	ask a doctor

Other Information (Other information)

store between 20-25°C (68-77°F)
retain carton for complete product information

Inactive Ingredients (Inactive ingredients)

povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

HyVee®

NDC 42507-103-04

*Compare to the Active Ingredient in Tylenol® Extra Strength

Extra Strength

Pain Relief

Acetaminophen, 500 mg

Pain Reliever / Fever Reducer

For Adults

Actual Size

100 TABLETS

Section 42229-5 (42229-5)

Drug Facts

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you aretaking the blood thinning drug warfarin

Section 50569-3 (50569-3)

Ask a doctor before use if you haveliver disease.

Section 53414-9 (53414-9)

If pregnant or breast-feeding,ask a health professional before 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 allergic to acetaminophen or any of the inactive ingredients in this product

Allergy Alert (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.

Liver Warning (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

Overdose Warning (Overdose warning)

Questions Or Comments? (Questions or comments?)

1-844-705-4384

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.

Advanced Ingredient Data

[{"name": "POVIDONE, UNSPECIFIED", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, PREGELATINIZED CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A CORN", "unii": "AG9B65PV6B", "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"}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves minor aches and pains due to: the common cold headache backache minor pain of arthritis toothache muscular aches premenstrual and menstrual cramps temporarily reduces fever", "42229-5": "Drug Facts", "50568-5": "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin", "50569-3": "Ask a doctor before use if you have liver disease.", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purpose": "Pain reliever/fever reducer", "Directions": "do not take more than directed (see overdose warning ) 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 use 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", "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.", "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", "Overdose warning": "In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.", "Other information": "store between 20-25°C (68-77°F) retain carton for complete product information", "Inactive ingredients": "povidone, pregelatinized starch, sodium starch glycolate, stearic acid", "Questions or comments?": "1-844-705-4384", "PRINCIPAL DISPLAY PANEL": "HyVee® NDC 42507-103-04 *Compare to the Active Ingredient in Tylenol® Extra Strength Extra Strength Pain Relief Acetaminophen, 500 mg Pain Reliever / Fever Reducer For Adults Actual Size 100 TABLETS", "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.", "Active ingredient (in each tablet)": "Acetaminophen 500 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:17.072243 · Updated: 2026-03-14T23:10:33.744870