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Unishield Ibuprofen
Ibuprofen · Tablet, Coated
Overview
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Ibuprofen | 200 mg/1 | 310965 | View |
Forms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Anti-Inflammatory Agents | EPC | All 251 members |
| Cyclooxygenase Inhibitors [MoA] | MoA | All 251 members |
| Non-Steroidal [CS] | CS | All 251 members |
| Nonsteroidal Anti-inflammatory Drug [EPC] | EPC | All 251 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 079174-001 | IBUPROFEN | TABLET | IBUPROFEN | Over-the-counter | — |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 14 | Labeling | Approved | April 11, 2018 | Standard |
| Supplement | 10 | Manufacturing (CMC) | Approved | April 11, 2018 | — |
| Supplement | 17 | Labeling | Approved | March 23, 2018 | Standard |
| Supplement | 1 | Labeling | Approved | April 13, 2015 | Standard |
| Original application | 1 | Approved | December 10, 2010 | — |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20250909). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingUses Temporarily relieves minor aches and pains associated with ■ headache ■ toothache ■ backache ■ menstrual cramps ■ common cold ■ muscular aches ■ minor arthritis pain Temporarily reduces fever.
Purpose
openFDA Drug LabelingPurpose Pain reliever/fever reducer
Dosage and Administration
openFDA Drug LabelingDirections ■ 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.
Warnings
openFDA Drug LabelingWarnings Allergy aler t: 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 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
openFDA Drug LabelingDo not use ■ if you have ever had an allergic reaction to any other pain reliever/fever reducer ■ right before or after heart surgery
Ask a Doctor
openFDA Drug LabelingAsk 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
Stop Use
openFDA Drug LabelingStop 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
Active Ingredient
openFDA Drug LabelingActive ingredient (in each tablet) Ibuprofen 200 mg (NSAID*) *nonsteroidal anti-inflammatory drug
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: IBUPROFEN. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 49314-0993-3 | 49314-0993 | Unishield | 50 PACKET in 1 BOX (49314-0993-3) / 2 TABLET, COATED in 1 PACKET | March 1, 2021 |
| 49314-1003-3 | 49314-1003 | Unishield | 50 PACKET in 1 BOX (49314-1003-3) / 2 TABLET, COATED in 1 PACKET | March 1, 2021 |
| 49314-0993 | 49314-0993 | Unishield | — | March 1, 2021 |
| 49314-1003 | 49314-1003 | Unishield | — | March 1, 2021 |
Sources for this page
| Dataset | Agency | Used for |
|---|---|---|
| NDC Directory | FDA | Identity, ingredients, strengths, forms, routes, labelers, packages |
| Drugs@FDA | FDA | Application, sponsor, submissions, review documents, marketing status |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
Generated September 25, 2026 · 10 sections on this page.