Advil 256 mg/1
ibuprofen sodium · TABLET, COATED · Haleon US Holdings LLC
Advil is a tablet, coated containing ibuprofen sodium at 256 mg/1, taken oral. Manufactured by Haleon US Holdings LLC.
Key Facts
- Brand Name
- Advil
- Generic Name
- ibuprofen sodium
- NDC Code (Product)
0573-0133- Manufacturer
- Haleon US Holdings LLC
- Strength
- 256 mg/1
- Dosage Form
- TABLET, COATED
- Route
- ORAL
- Marketing Status
- Application #
- NDA201803
- Marketing Start
- 07/08/2013
Recall History
Family Dollar Stores, Llc.
CGMP deviation: product outside labeled storage temperature requirements.
Glaxosmithkline Consumer Healthcare Holdings
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Glaxosmithkline Consumer Healthcare Holdings
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Glaxosmithkline Consumer Healthcare Holdings
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
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
Family Dollar Stores, Llc.
CGMP deviation: product outside labeled storage temperature requirements.
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
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.
Family Dollar Stores, Llc.
CGMP deviation: product outside labeled storage temperature requirements.
GOLD STAR DISTRIBUTION INC
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Uses Uses temporarily relieves minor aches and pains due to: headache toothache backache menstrual cramps muscular aches minor pain of arthritis
Dosage & Administration
Directions Directions Do not take more than directed adults and children 12 years and over take 2 caplets every 8 hours while symptoms persist children under 12 years ask a doctor do not take more than 6 caplets in 24 hours, unless directed by a doctor
Warnings
Warnings Warnings Acetaminophen liver damage warning Acetaminophen liver damage warning: This product contains acetaminophen. Severe liver damage may occur if you take: with other drugs containing acetaminophen more than 6 caplets in 24 hours, which is the maximum daily amount for this product 3 or more alcoholic drinks every day while using this product Acetaminophen allergy alert Acetaminophen allergy alert: may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If skin reaction occurs, stop use and seek medical help right away. NSAID allergy alert NSAID allergy alert: ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away. NSAID stomach bleeding warning NSAID stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or no…
Frequently Asked Questions
What is Advil used for?
Advil contains ibuprofen sodium. It is a tablet, coated taken oral. Consult your doctor for specific uses.
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 sodium. There are 1 other brand versions of ibuprofen sodium.
What is the NDC code for Advil 256 mg/1?
The NDC (National Drug Code) for Advil 256 mg/1 is 0573-0133, listed by Haleon US Holdings LLC.