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

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

Active Ingredient

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

Purpose

Pain reliever/fever reducer

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.

Inactive Ingredients

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

Description

Acetaminophen 500mg

Questions?

Adverse drug event call: (866) 562-2756

Repackaged by:

Proficient Rx LP

Thousand Oaks, CA 91320

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

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

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.

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 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

Active Ingredient (Active ingredient (in each tablet))

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

Purpose

Pain reliever/fever reducer

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.

Inactive Ingredients (Inactive ingredients)

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

Questions?

Adverse drug event call: (866) 562-2756

Repackaged by:

Proficient Rx LP

Thousand Oaks, CA 91320

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

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

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.

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": "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