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

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 325mg


Medication Information

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.

Active Ingredient

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
Purpose

Pain reliever/fever reducer

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

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)
Inactive Ingredients

povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Description

Acetaminophen 325mg

Questions?

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

DISTRIBUTED BY: 

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL 33179

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

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:

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

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.

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

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.

Active Ingredient (Active ingredient (in each tablet))

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
Purpose

Pain reliever/fever reducer

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

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)
Inactive Ingredients (Inactive ingredients)

povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Questions?

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

DISTRIBUTED BY: 

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL 33179

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

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:)

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

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.

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

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