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NDC 00404-0017-13 Henry Schein Ibuprofen 200 mg/1 Details
Henry Schein Ibuprofen 200 mg/1
Henry Schein Ibuprofen is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Henry Schein Inc.. The primary component is IBUPROFEN.
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: 00404-0017-13Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Ibuprofen
Product Information
NDC | 00404-0017 |
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Product ID | 0404-0017_dee5b919-5ac5-d882-e053-2995a90a8742 |
Associated GPIs | 66100020000305 |
GCN Sequence Number | 008346 |
GCN Sequence Number Description | ibuprofen TABLET 200 MG ORAL |
HIC3 | S2B |
HIC3 Description | NSAIDS, CYCLOOXYGENASE INHIBITOR TYPE ANALGESICS |
GCN | 35743 |
HICL Sequence Number | 003723 |
HICL Sequence Number Description | IBUPROFEN |
Brand/Generic | Generic |
Proprietary Name | Henry Schein Ibuprofen |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Ibuprofen |
Product Type | HUMAN OTC DRUG |
Dosage Form | TABLET, FILM COATED |
Route | ORAL |
Active Ingredient Strength | 200 |
Active Ingredient Units | mg/1 |
Substance Name | IBUPROFEN |
Labeler Name | Henry Schein Inc. |
Pharmaceutical Class | Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC] |
DEA Schedule | n/a |
Marketing Category | ANDA |
Application Number | ANDA075010 |
Listing Certified Through | 2024-12-31 |
Package
Package Images

NDC 00404-0017-13 (00404001713)
NDC Package Code | 0404-0017-13 |
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Billing NDC | 00404001713 |
Package | 250 PACKET in 1 BOX (0404-0017-13) / 2 TABLET, FILM COATED in 1 PACKET (0404-0017-99) |
Marketing Start Date | 2015-12-15 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 267c7c8a-2f3f-1f4d-e054-00144ff8d46c Details
SPL UNCLASSIFIED SECTION
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Warnings
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin.
Symptoms may include:
■ hives ■ skin reddening ■ asthma (wheezing) ■ facial swelling ■ rash ■ shock ■ 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
■ 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 or 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.
SPL UNCLASSIFIED SECTION
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Ask a doctor before use if
■ you have problems or serious side effects from taking pain relievers or fever reducers
■ stomach bleeding warning applies to you
■ 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
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Stop use and ask a doctor if
■ 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:
■ chest pain ■ trouble breathing ■ weakness in one part or side of body ■ slurred speech ■ leg swelling
■ pain gets worse or lasts for more than 10 days
■ fever gets worse or lasts for more than 3 days
■ redness or swelling is present in the painful area
■ any new or unexpected symptoms occur
SPL UNCLASSIFIED SECTION
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Directions
■ do not use more than directed
■ the smallest effective dose should be used
■ do not take longer than 10 days, unless directed by a doctor (see Warnings)
Adults and children:(12 years and older)
Take 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, 2 tablets may be used.
Do not exceed 6 tablets in 24 hours, unless directed by a doctor.
Children under 12 years:
Ask a doctor
SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL
Henry Schein®
Ibuprofen
NDC #0404-0017-13
For temporary relief of minor aches and pains associated with headache, toothache, backache, menstrual cramps, common cold, muscular aches, minor arthritis pain and for the reduction of fever.
Henry Schein
Seal Of Excellence®
This Package is for Households Without Young Children.
Ibuprofen 200 mg
(NSAID)
250 Packets/2 Tablets
Reorder
570-0177
INGREDIENTS AND APPEARANCE
HENRY SCHEIN IBUPROFEN
ibuprofen tablet, film coated |
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Labeler - Henry Schein Inc. (012430880) |
Registrant - Unifirst First Aid Corporation (832947092) |