Drug Facts

Drug Facts

SPL v3

SPL

SPL Set ID 27337be9-e279-460e-903e-ae4463099599

Route

ORAL

Published

Effective Date 2025-12-24

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Acetaminophen (500 mg)

Inactive Ingredients

Hypromellose, Unspecified Povidone, Unspecified Starch, Corn Sodium Starch Glycolate Type A Corn Stearic Acid Talc Triacetin

Identifiers & Packaging

Pill Appearance

Imprint: PH016 Shape: capsule Color: white Size: 18 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2018-03-01

Description

Acetaminophen 500mg

Purpose

Pain Reliever/fever reducer

Medication Information

Purpose

Pain Reliever/fever reducer

Description

Acetaminophen 500mg

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

Section 51945-4

PHARBEST

NDC 16103-350-08

Manufactured in the USA

Etra Strength

*COMPARE TO the active ingredients in Etra Strength TYLENOL® Caplet

PHARBETOL

Acetaminophen 500 mg each

Pain Reliever/Fever Reducer

THIS PACKAGE FOR HOUSEHOLD WITHOUT YOUNG CHILDREN

100 CAPLETS

Warnings

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

more than 4000 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 (see overdose warning)

adults and children 12 years and over	take 2 caplets, every 6 hours while symptoms last do not take more than 6 caplets in 24 hours, unless directed by a doctor do not use 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

Other Information

Tamper Evident: do not use if imprinted safety seal under cap is broken or missing
store at 20^o-25^oC (68^o-77^oF), excursions permitted between 15-30°C (59-86°F)

Overdose Warning:

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

Inactive Ingredients

hypromellose, povidone, pregelatinized corn starch, sodium starch glycolate, stearic acid, talc, triacetin

Questions Or Comments?

(866) 562-2756 (Mon - Fri 8 AM to 4 PM EST)

Ask A Doctor Before Use

if you have liver disease.

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.

Keep Out of Reach of Children.

Active Ingredient (in Each Caplet)

Acetaminophen 500mg

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin.

Structured Label Content

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

Section 51945-4 (51945-4)

PHARBEST

NDC 16103-350-08

Manufactured in the USA

Etra Strength

*COMPARE TO the active ingredients in Etra Strength TYLENOL® Caplet

PHARBETOL

Acetaminophen 500 mg each

Pain Reliever/Fever Reducer

THIS PACKAGE FOR HOUSEHOLD WITHOUT YOUNG CHILDREN

100 CAPLETS

Purpose

Pain Reliever/fever reducer

Warnings

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

more than 4000 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 (see overdose warning)

adults and children 12 years and over	take 2 caplets, every 6 hours while symptoms last do not take more than 6 caplets in 24 hours, unless directed by a doctor do not use more than 10 days unless directed by a doctor
children under 12 years	ask 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 are allergic to acetaminophen or any of the inactive ingredients in this product

Other Information (Other information)

Tamper Evident: do not use if imprinted safety seal under cap is broken or missing
store at 20^o-25^oC (68^o-77^oF), excursions permitted between 15-30°C (59-86°F)

Overdose Warning: (Overdose warning:)

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

Inactive Ingredients (Inactive ingredients)

hypromellose, povidone, pregelatinized corn starch, sodium starch glycolate, stearic acid, talc, triacetin

Questions Or Comments? (Questions or comments?)

(866) 562-2756 (Mon - Fri 8 AM to 4 PM EST)

Ask A Doctor Before Use (Ask a doctor before use)

if you have liver disease.

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.

Keep Out of Reach of Children. (Keep out of reach of children.)

Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))

Acetaminophen 500mg

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": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "500", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "HYPROMELLOSE, UNSPECIFIED", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE, UNSPECIFIED", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, 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": "TALC", "unii": "7SEV7J4R1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRIACETIN", "unii": "XHX3C3X673", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

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", "51945-4": "PHARBEST NDC 16103-350-08 Manufactured in the USA Etra Strength *COMPARE TO the active ingredients in Etra Strength TYLENOL® Caplet PHARBETOL Acetaminophen 500 mg each Pain Reliever/Fever Reducer THIS PACKAGE FOR HOUSEHOLD WITHOUT YOUNG CHILDREN 100 CAPLETS", "Purpose": "Pain Reliever/fever reducer", "Warnings": "Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4000 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 (see overdose warning) adults and children 12 years and over take 2 caplets, every 6 hours while symptoms last do not take more than 6 caplets in 24 hours, unless directed by a doctor do not use 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", "Other information": "Tamper Evident: do not use if imprinted safety seal under cap is broken or missing store at 20 o -25 o C (68 o -77 o F), excursions permitted between 15-30°C (59-86°F)", "Overdose warning:": "In the case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222).", "Inactive ingredients": "hypromellose, povidone, pregelatinized corn starch, sodium starch glycolate, stearic acid, talc, triacetin", "Questions or comments?": "(866) 562-2756 (Mon - Fri 8 AM to 4 PM EST)", "Ask a doctor before use": "if you have liver disease.", "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.", "Active ingredient (in each caplet)": "Acetaminophen 500mg", "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: 2026-02-15T12:07:53.396175 · Updated: 2026-03-14T23:11:51.346073