Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (500 mg)

Inactive Ingredients

Povidone K30 Starch, Corn Sodium Starch Glycolate Type A Potato Stearic Acid

Identifiers & Packaging

Pill Appearance

Imprint: PH044 Shape: round Color: white Size: 12 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2006-01-10

Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 500mg

Uses

Temporarily relieves minor aches and pains due to:

•
headache
•
backache
•
minor pain of arthritis
•
toothache
•
muscular aches
•
menstrual cramps

Temporarily reduces fever

Section 51945-4

NDC 71205-990-00

Manufactured in the USA

Extra Strength *Compare to the active ingredient in Extra Strength Tylenol Caplet

Do not use any other product containing acetaminophen

Acetaminophen 500mg

Pain Reliever Fever Reducer

100 Tablets

Warnings

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

•
more than 8 tablets in 24 hours, which is the maximum daily amount
•
with other drugs containing acetaminophen
•
3 or more alcoholic drinks every day while using this product

Directions

•
do not take more than directed (see overdose warning).
•
Adult and Children 12 years and over: take 2 tablets, every 4 to 6 hours while symptoms last. Do not take more than 8 tablets in 24 hours. Do not take for more than 10 days unless directed by a doctor.
•
Children under 12 years: do not use adult extra strength product in children under 12 years of age; this will provide more than recommended dose (overdose) and may cause liver damage.

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

Questions?

Adverse drug event call: (866) 562-2756

Repackaged by:

Proficient Rx LP

Thousand Oaks, CA 91320

Overdose Warning:

Taking more than the recommended dose (overdose) may cause liver damage. In the case of overdose, get medical help or contact a Poison Control Center right away.

Inactive Ingredients

Povidone, Pregelatinized corn starch, sodium starch glycolate, stearic acid.

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 Tablet)

Acetaminophen 500mg

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

Uses

Temporarily relieves minor aches and pains due to:

•
headache
•
backache
•
minor pain of arthritis
•
toothache
•
muscular aches
•
menstrual cramps

Temporarily reduces fever

Section 51945-4 (51945-4)

NDC 71205-990-00

Manufactured in the USA

Extra Strength *Compare to the active ingredient in Extra Strength Tylenol Caplet

Do not use any other product containing acetaminophen

Acetaminophen 500mg

Pain Reliever Fever Reducer

100 Tablets

Purpose

Pain reliever/fever reducer

Warnings

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

•
more than 8 tablets in 24 hours, which is the maximum daily amount
•
with other drugs containing acetaminophen
•
3 or more alcoholic drinks every day while using this product

Directions

•
do not take more than directed (see overdose warning).
•
Adult and Children 12 years and over: take 2 tablets, every 4 to 6 hours while symptoms last. Do not take more than 8 tablets in 24 hours. Do not take for more than 10 days unless directed by a doctor.
•
Children under 12 years: do not use adult extra strength product in children under 12 years of age; this will provide more than recommended dose (overdose) and may cause liver damage.

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

Questions?

Adverse drug event call: (866) 562-2756

Repackaged by:

Proficient Rx LP

Thousand Oaks, CA 91320

Overdose Warning: (Overdose warning:)

Taking more than the recommended dose (overdose) may cause liver damage. In the case of overdose, get medical help or contact a Poison Control Center right away.

Inactive Ingredients (Inactive ingredients)

Povidone, Pregelatinized corn starch, sodium starch glycolate, stearic acid.

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.

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

Acetaminophen 500mg

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": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "500", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "POVIDONE K30", "unii": "U725QWY32X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A POTATO", "unii": "5856J3G2A2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "Temporarily relieves minor aches and pains due to: • headache • backache • minor pain of arthritis • toothache • muscular aches • menstrual cramps Temporarily reduces fever", "51945-4": "NDC 71205-990-00 Manufactured in the USA Extra Strength *Compare to the active ingredient in Extra Strength Tylenol Caplet Do not use any other product containing acetaminophen Acetaminophen 500mg Pain Reliever Fever Reducer 100 Tablets", "Purpose": "Pain reliever/fever reducer", "Warnings": "Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 8 tablets in 24 hours, which is the maximum daily amount • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using this product", "Directions": "• do not take more than directed (see overdose warning). • Adult and Children 12 years and over: take 2 tablets, every 4 to 6 hours while symptoms last. Do not take more than 8 tablets in 24 hours. Do not take for more than 10 days unless directed by a doctor. • Children under 12 years: do not use adult extra strength product in children under 12 years of age; this will provide more than recommended dose (overdose) and may cause liver damage.", "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", "Questions?": "Adverse drug event call: (866) 562-2756 Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320", "Overdose warning:": "Taking more than the recommended dose (overdose) may cause liver damage. In the case of overdose, get medical help or contact a Poison Control Center right away.", "Inactive ingredients": "Povidone, Pregelatinized corn starch, sodium starch glycolate, stearic acid.", "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 tablet)": "Acetaminophen 500mg", "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"}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information