pharbetol extra stength tablet

pharbetol extra stength tablet
SPL v5
SPL
SPL Set ID 04dbd98f-c74d-43b2-8bda-74f18be7cf6c
Route
oral
Published
Effective Date 2025-12-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

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

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 500 mg


Medication Information

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.

Active Ingredient

Acetaminophen 500 mg

Uses
  • temporarily relieves minor aches and pains due to:
  • 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).

adult 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 at 20-250 C (68-77 0 F)
Inactive Ingredients

povidone, pregelatinized corn starch, sodium starch glycolate, stearic acid

Description

Acetaminophen 500 mg

Section 51945-4

PHARBEST

NDC 16103-376-11

manufactured in the USA

Extra Strength Contains no Aspirin

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

PHARBETOL

Acetaminophen 500 mg each

Pain Reliever/Fever Reducer

THIS PACKAGE FOR HOUSEHOLD WITHOUT YOUNG CHILDREN

1000 TABLETS

TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

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 Or Comments?

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

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
  • redness or swelling is present
  • new symptoms occur

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). Quick medical attention is critical for adults as well as for children even if you don't notice any signs or symptoms.

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 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.

Active Ingredient (Active ingredient (in each tablet))

Acetaminophen 500 mg

Uses
  • temporarily relieves minor aches and pains due to:
  • 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).

adult 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 at 20-250 C (68-77 0 F)
Inactive Ingredients (Inactive ingredients)

povidone, pregelatinized corn starch, sodium starch glycolate, stearic acid

Section 51945-4 (51945-4)

PHARBEST

NDC 16103-376-11

manufactured in the USA

Extra Strength Contains no Aspirin

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

PHARBETOL

Acetaminophen 500 mg each

Pain Reliever/Fever Reducer

THIS PACKAGE FOR HOUSEHOLD WITHOUT YOUNG CHILDREN

1000 TABLETS

TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

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 Or Comments? (Questions or comments?)

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

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
  • redness or swelling is present
  • new symptoms occur

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). Quick medical attention is critical for adults as well as for children even if you don't notice any signs or symptoms.

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


Raw Label Data

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