Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (500 mg)

Inactive Ingredients

Povidone, Unspecified 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 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

Section 51945-4

Repackaged By:

Proficient Rx LP

Thousand Oaks, CA 91320

NDC 71205-478-50

manufactured in the USA

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

Do not use with any other product containing acetaminophen

PHARBETOL

Acetaminophen 500mg

Pain Reliever • Fever Reducer

50 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

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).

adult and children 12 years and over	• take 2 tablets, every 4 to 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

Questions?

Adverse drug event call: 1-866-562-2756 Mon - Fri: 8 AM to 4 PM

Other Information

•
Tamper Evident: do not use if imprinted safety seal under cap is broken or missing
•
store between 20-25⁰C (68-77⁰F)

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.

Keep Out of Reach of Children.

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

Active Ingredient (in Each Tablet)

Acetaminophen 500 mg

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

Section 51945-4 (51945-4)

Repackaged By:

Proficient Rx LP

Thousand Oaks, CA 91320

NDC 71205-478-50

manufactured in the USA

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

Do not use with any other product containing acetaminophen

PHARBETOL

Acetaminophen 500mg

Pain Reliever • Fever Reducer

50 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

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).

adult and children 12 years and over	• take 2 tablets, every 4 to 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 (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: 1-866-562-2756 Mon - Fri: 8 AM to 4 PM

Other Information (Other information)

•
Tamper Evident: do not use if imprinted safety seal under cap is broken or missing
•
store between 20-25⁰C (68-77⁰F)

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.

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

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

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

Acetaminophen 500 mg

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, 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 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: • the common cold • headache • backache • minor pain of arthritis • toothache • muscular aches • premenstrual and menstrual cramps • temporarily reduces fever", "51945-4": "Repackaged By: Proficient Rx LP Thousand Oaks, CA 91320 NDC 71205-478-50 manufactured in the USA Extra Strength *Compare to the active ingredient in Extra Strength Tylenol® Caplet Do not use with any other product containing acetaminophen PHARBETOL Acetaminophen 500mg Pain Reliever • Fever Reducer 50 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 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). adult and children 12 years and over • take 2 tablets, every 4 to 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", "Questions?": "Adverse drug event call: 1- 866-562-2756 Mon - Fri: 8 AM to 4 PM", "Other information": "• Tamper Evident: do not use if imprinted safety seal under cap is broken or missing • store between 20-25 0 C (68-77 0 F)", "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.", "Keep out of reach of children.": "Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)", "Active ingredient (in each tablet)": "Acetaminophen 500 mg", "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