Pharbest Ibuprofen

Pharbest Ibuprofen
SPL v3
SPL
SPL Set ID 05a91d24-b498-4ba2-a275-68b871cf62d2
Route
ORAL
Published
Effective Date 2024-06-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg)
Inactive Ingredients
Povidone Starch, Corn Sodium Starch Glycolate Type A Corn Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: PH020 Shape: round Color: white Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2007-01-09

Description

Acetaminophen 325mg

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 325mg

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 17856-0353-01

Manufactured in the USA

Contains no Aspirin

Regular Strength

Acetaminophen 325mg each

Pain Reliever • Fever Reducer

100 TAB

Warnings

Liver warning:This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children.

Severe liver damage may occur if

  • adult takes more than 4,000 mg of acetaminophen in 24 hours
  • child takes more than 5 doses in 24 hours, which is the maximum daily amount
  • taken with other drugs containing acetaminophen
  • adult has 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 tablets, every 4 to 6 hours while symptoms last
  • do not take more than 10 tablets in 24 hours, unless directe by a doctor
  • do not use for more than 10 days unless directed by a doctor
children 6 to 11 years
  • take 1 tablet every 4 to 6 hours while symptoms last
  • do not take more than 5 tablets in 24 hours
  • do not use for more than 5 days unless directed by a doctor
children under 6 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:(866) 562-2756 Mon-Fri 8 AM to 4 PM

DISTRIBUTED BY: 

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL 33179

Other Information
  • Tamper Evident: do not use if imprinted safety seal under cap is broken or missing
  • store between 20-25°C (68-77°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

povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Stop Use and Ask A Doctor If
  • pain gets worse or lasts more than 10 days in adults 
  • pain gets worse or lasts more than 5 days in children under 12 years
  • 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 325mg

Keep Out of the Reach of Children.

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)

PHARBEST

NDC 17856-0353-01

Manufactured in the USA

Contains no Aspirin

Regular Strength

Acetaminophen 325mg each

Pain Reliever • Fever Reducer

100 TAB

Purpose

Pain reliever/fever reducer

Warnings

Liver warning:This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children.

Severe liver damage may occur if

  • adult takes more than 4,000 mg of acetaminophen in 24 hours
  • child takes more than 5 doses in 24 hours, which is the maximum daily amount
  • taken with other drugs containing acetaminophen
  • adult has 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 tablets, every 4 to 6 hours while symptoms last
  • do not take more than 10 tablets in 24 hours, unless directe by a doctor
  • do not use for more than 10 days unless directed by a doctor
children 6 to 11 years
  • take 1 tablet every 4 to 6 hours while symptoms last
  • do not take more than 5 tablets in 24 hours
  • do not use for more than 5 days unless directed by a doctor
children under 6 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:(866) 562-2756 Mon-Fri 8 AM to 4 PM

DISTRIBUTED BY: 

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL 33179

Other Information (Other information)
  • Tamper Evident: do not use if imprinted safety seal under cap is broken or missing
  • store between 20-25°C (68-77°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)

povidone, pregelatinized 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 in adults 
  • pain gets worse or lasts more than 5 days in children under 12 years
  • 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 325mg

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

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

All Sections (JSON)