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NDC 00573-0133-02 Advil 256 mg/1 Details
Advil 256 mg/1
Advil is a ORAL TABLET, COATED in the HUMAN OTC DRUG category. It is labeled and distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. The primary component is IBUPROFEN SODIUM.
MedlinePlus Drug Summary
Prescription ibuprofen is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints) and rheumatoid arthritis (arthritis caused by swelling of the lining of the joints). It is also used to relieve mild to moderate pain, including menstrual pain (pain that happens before or during a menstrual period). Nonprescription ibuprofen is used to reduce fever and to relieve minor aches and pain from headaches, muscle aches, arthritis, menstrual periods, the common cold, toothaches, and backaches. Ibuprofen is in a class of medications called NSAIDs. It works by stopping the body's production of a substance that causes pain, fever, and inflammation.
Related Packages: 00573-0133-02Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Ibuprofen
Product Information
| NDC | 00573-0133 |
|---|---|
| Product ID | 0573-0133_4e46a19d-ca33-44b9-bf35-a1da6a4be764 |
| Associated GPIs | 66100020000305 |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Advil |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | ibuprofen sodium |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, COATED |
| Route | ORAL |
| Active Ingredient Strength | 256 |
| Active Ingredient Units | mg/1 |
| Substance Name | IBUPROFEN SODIUM |
| Labeler Name | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC |
| Pharmaceutical Class | Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA201803 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 00573-0133-02 (00573013302)
| NDC Package Code | 0573-0133-02 |
|---|---|
| Billing NDC | 00573013302 |
| Package | 50 PACKET in 1 TRAY (0573-0133-02) / 2 TABLET, COATED in 1 PACKET |
| Marketing Start Date | 2013-07-08 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 5be198b8-396e-4b44-8819-e2e3b5d2ad0e Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Warnings
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
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- blisters
If an allergic reaction occurs, stop use and seek medical help right away.
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
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- take a blood thinning (anticoagulant) or steroid drug
- •
- take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
- •
- have 3 or more alcoholic drinks every day while using this product
- •
- take more or for a longer time than directed
Heart attack and stroke warning
NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.
Do not use
- •
- if you have ever had an allergic reaction to any other pain reliever/fever reducer
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- right before or after heart surgery
Ask a doctor before use if
- •
- stomach bleeding warning applies to you
- •
- you have problems or serious side effects from taking pain relievers or fever reducers
- •
- you have a history of stomach problems, such as heartburn
- •
- you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
- •
- you are taking a diuretic
Ask a doctor or pharmacist before use if you are
- •
- under a doctor's care for any serious condition
- •
- taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
- •
- taking any other drug
Stop use and ask a doctor if
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- you experience any of the following signs of stomach bleeding:
- •
- feel faint
- •
- vomit blood
- •
- have bloody or black stools
- •
- have stomach pain that does not get better
- •
- you have symptoms of heart problems or stroke:
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- chest pain
- •
- trouble breathing
- •
- weakness in one part or side of body
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- slurred speech
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- leg swelling
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- pain gets worse or lasts more than 10 days
- •
- fever gets worse or lasts more than 3 days
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- redness or swelling is present in the painful area
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- any new symptoms appear
SPL UNCLASSIFIED SECTION
Directions
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- do not take more than directed
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- the smallest effective dose should be used
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- adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persist
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- if pain or fever does not respond to 1 tablet, 2 tablets may be used
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- do not exceed 6 tablets in 24 hours, unless directed by a doctor
- •
- children under 12 years: ask a doctor
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Inactive ingredients
acesulfame potassium, caramel color, carnauba wax, colloidal silicon dioxide, copovidone, ferric oxide, hypromellose, mannitol, medium-chain triglycerides, microcrystalline cellulose, natural and artificial flavor, pharmaceutical ink, polyethylene glycol, propylene glycol, sodium lauryl sulfate, sucralose, titanium dioxide
Additional Information
Do Not Use if the sealed child resistant pouch is broken or torn.
For most recent product information, visit www.Advil.com
For US Patent or Application status see www.productpats.com
Distributed by: GSK Consumer Healthcare, Warren, NJ 07059
Trademarks are owned by or licensed to the GSK group of companies
©2021 GSK group of companies or its licensor
PRINCIPAL DISPLAY PANEL
NDC 0573-0133-02
Advil
FILM-COATED
IBUPROFEN
SODIUM
Ibuprofen Tablets, 200 mg
(Provided as Ibuprofen Sodium 256 mg)
Pain Reliever / Fever Reducer (NSAID)
Advil Tablets
- •
- Headache
- •
- Muscular Aches
- •
- Minor Pain of Arthritis
- •
- Menstrual Cramps
- •
- Toothache
- •
- Fever
See Full Drug Facts information on the back of this dispenser
100 TABLETS
(50 PACKETS of 2 TABLETS EACH)
000068427 Front Carton
PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
| ADVIL
ibuprofen sodium tablet, coated |
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| ADVIL
ibuprofen sodium tablet, coated |
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| Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Wyeth Pharmaceuticals Company | 829390975 | ANALYSIS(0573-0133, 0573-0134) , LABEL(0573-0133, 0573-0134) , MANUFACTURE(0573-0133, 0573-0134) , PACK(0573-0133, 0573-0134) | |