Drugplain

ADVIL 200 mg/1

ibuprofen · TABLET, COATED · Haleon US Holdings LLC

10 Recalls on Record
Plain English

Advil is an over-the-counter pain reliever and anti-inflammatory medication containing 200 mg of ibuprofen per coated tablet, taken by mouth to reduce minor aches, pains, and fever. As a nonsteroidal anti-inflammatory drug (NSAID), it works by decreasing inflammation and blocking pain signals in the body.

Key Facts

Brand Name
ADVIL
Generic Name
ibuprofen
NDC Code (Product)
0573-0154
Manufacturer
Haleon US Holdings LLC
Strength
200 mg/1
Dosage Form
TABLET, COATED
Route
ORAL
Marketing Status
Application #
NDA018989
Drug Class
Nonsteroidal Anti-inflammatory Drug [EPC]
Marketing Start
05/18/1984

Recall History

10 Recalls on Record
Class II03/31/2023

Family Dollar Stores, Llc.

CGMP deviation: product outside labeled storage temperature requirements.

OngoingVoluntary: Firm initiated
Class II03/16/2020

Glaxosmithkline Consumer Healthcare Holdings

Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.

TerminatedVoluntary: Firm initiated
Class II03/16/2020

Glaxosmithkline Consumer Healthcare Holdings

Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.

TerminatedVoluntary: Firm initiated
Class II03/16/2020

Glaxosmithkline Consumer Healthcare Holdings

Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.

TerminatedVoluntary: Firm initiated
Class I12/06/2022

Glaxosmithkline Consumer Healthcare Holdings DBA Haleon

Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back

TerminatedVoluntary: Firm initiated
Class II03/31/2023

Family Dollar Stores, Llc.

CGMP deviation: product outside labeled storage temperature requirements.

OngoingVoluntary: Firm initiated
Class I12/06/2022

Glaxosmithkline Consumer Healthcare Holdings DBA Haleon

Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back

TerminatedVoluntary: Firm initiated
Class II08/23/2018

Pfizer Global Supply

Labeling Error: Not elsewhere classified. product has a dosage cup marked in teaspoons and the instructions on the label are described in milliliters.

TerminatedVoluntary: Firm initiated
Class II03/31/2023

Family Dollar Stores, Llc.

CGMP deviation: product outside labeled storage temperature requirements.

OngoingVoluntary: Firm initiated
Class II12/26/2025

GOLD STAR DISTRIBUTION INC

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

OngoingVoluntary: Firm initiated

Frequently Asked Questions

What is ADVIL used for?

Advil is an over-the-counter pain reliever and anti-inflammatory medication containing 200 mg of ibuprofen per coated tablet, taken by mouth to reduce minor aches, pains, and fever. As a nonsteroidal anti-inflammatory drug (NSAID), it works by decreasing inflammation and blocking pain signals in the body.

Is ADVIL a controlled substance?

ADVIL is not classified as a controlled substance by the DEA.

What is the generic name for ADVIL?

The generic name for ADVIL is ibuprofen. There are 12 other brand versions of ibuprofen.

What is the NDC code for ADVIL 200 mg/1?

The NDC (National Drug Code) for ADVIL 200 mg/1 is 0573-0154, listed by Haleon US Holdings LLC.