Active Ingredients And Purpose
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each tablet) Ibuprofen 200 mg (NSAID*) *nonsteroidal anti-inflammatory drug
OTC - PURPOSE SECTION
Purpose Pain reliever/fever reducer
Unishield Ibuprofen
- Manufacturer
- Unishield | Unifirst First Aid Corporation
- Effective date
- 2025-09-09
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-06-01 01:13:18
Key Label Information#
Uses
INDICATIONS & USAGE SECTION
Uses Temporarily relieves minor aches and pains associated with ■ headache ■ toothache ■ backache ■ menstrual cramps ■ common cold ■ muscular aches ■ minor arthritis pain Temporarily reduces fever.
Warnings
WARNINGS SECTION
Warnings 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.
OTC - DO NOT USE SECTION
Do not use ■ if you have ever had an allergic reaction to any other pain reliever/fever reducer ■ right before or after heart surgery
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Directions And Dosage
DOSAGE & ADMINISTRATION SECTION
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.
Other Label Information
INACTIVE INGREDIENT SECTION
Inactive ingredients carnauba wax*, corn starch, hypromellose*, iron oxide red, lactose*, magnesium stearate*, microcrystalline cellulose*, polydextrose*, polyethylene glycol, polyvinyl alcohol*, povidone K30*, silicon dioxide, sodium starch glycolate, stearic acid, talc*, titanium dioxide *may contain
OTC - QUESTIONS SECTION
Questions or comments? 800-480-5855
Unishield Ibuprofen Label
Unishield Ibuprofen 200 mg Pain Reliever/Fever Reducer (NSAID) 100 Tablets/ 1 Tablet Per Packet Pull To Open This Package is for Households without Young Children. • Temporary relief from pain, fever and inflammation • Soothes muscle aches and minor arthritis pain Compare active ingredient to: Advil® Registered Trademark of Pfizer Consumer Healthcare Tamper Evident Unit Dose Packets
Unishield Ibuprofen Label
Unishield Ibuprofen 200 mg Pain Reliever/Fever Reducer (NSAID) 100 Tablets/ 1 Tablet Per Packet Pull To Open This Package is for Households without Young Children. • Temporary relief from pain, fever and inflammation • Soothes muscle aches and minor arthritis pain Compare active ingredient to: Advil® Registered Trademark of Pfizer Consumer Healthcare Tamper Evident Unit Dose Packets
Label Images#
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| IBUPROFEN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20191108 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 1e73f975-1ce7-705e-2bcf-788b1b5e24ba | Product name | 5 | 20251124 |
| 16cde546-8deb-4df2-a072-dab5566ede95 | Product name | 1 | 20231003 |
| f6d1b8d7-3bd1-4248-eddd-b60565c88015 | Product name | 4 | 20230808 |
| 874f4e63-49d2-5150-5d77-052172814ebd | Product name | 6 | 20230105 |
| 557673c2-8256-b351-e863-4ec71a5a64b0 | Product name | 2 | 20160714 |
| dbc9a339-6215-4e94-9546-57a3b34902ce | Product name | 1 | 20160517 |
| 61c18d4e-b552-5478-8fc0-df38b93e3100 | Product name | 1 | 20140508 |
| 7b2938c9-7eb7-e312-ae90-f54f4240361e | Product name | 1 | 20140508 |
| 997601aa-bb5f-6971-6b90-a21132c12c7b | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49314-0993-3 | Unishield Ibuprofen | 2 in 1 PACKET | TABLET, COATED | 2 | 5 | |
| 49314-0993-3 | Unishield Ibuprofen | 50 in 1 BOX | TABLET, COATED | 50 | 5 | |
| 49314-1003-3 | Unishield Ibuprofen | 2 in 1 PACKET | TABLET, COATED | 2 | 5 | |
| 49314-1003-3 | Unishield Ibuprofen | 50 in 1 BOX | TABLET, COATED | 50 | 5 |
Products#
- Unishield Ibuprofen
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 49314-1003 | 49314-1003-3 |
| 49314-0993 | 49314-0993-3 |
Ingredients#
Complete SPL Sections#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each tablet) Ibuprofen 200 mg (NSAID*) *nonsteroidal anti-inflammatory drug
OTC - PURPOSE SECTION
Purpose Pain reliever/fever reducer
INDICATIONS & USAGE SECTION
Uses Temporarily relieves minor aches and pains associated with ■ headache ■ toothache ■ backache ■ menstrual cramps ■ common cold ■ muscular aches ■ minor arthritis pain Temporarily reduces fever.
WARNINGS SECTION
Warnings 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.
OTC - DO NOT USE SECTION
Do not use ■ if you have ever had an allergic reaction to any other pain reliever/fever reducer ■ right before or after heart surgery
OTC - ASK DOCTOR SECTION
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
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are ■ taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin ■ under a doctor’s care for any serious condition ■ taking any other drug
OTC - WHEN USING SECTION
When using this product ■ take with food or milk if stomach upset occurs
OTC - STOP USE 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
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
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.
OTHER SAFETY INFORMATION
Other information ■ read all product information before using ■ store at 68-77°F (20-25°C) ■ avoid excessive heat 40°C (above 104°F) ■ tamper evident sealed packets ■ do not use any opened or torn packets
INACTIVE INGREDIENT SECTION
Inactive ingredients carnauba wax*, corn starch, hypromellose*, iron oxide red, lactose*, magnesium stearate*, microcrystalline cellulose*, polydextrose*, polyethylene glycol, polyvinyl alcohol*, povidone K30*, silicon dioxide, sodium starch glycolate, stearic acid, talc*, titanium dioxide *may contain
OTC - QUESTIONS SECTION
Questions or comments? 800-480-5855
Unishield Ibuprofen Label
Unishield Ibuprofen 200 mg Pain Reliever/Fever Reducer (NSAID) 100 Tablets/ 1 Tablet Per Packet Pull To Open This Package is for Households without Young Children. • Temporary relief from pain, fever and inflammation • Soothes muscle aches and minor arthritis pain Compare active ingredient to: Advil® Registered Trademark of Pfizer Consumer Healthcare Tamper Evident Unit Dose Packets
Unishield Ibuprofen Label
Unishield Ibuprofen 200 mg Pain Reliever/Fever Reducer (NSAID) 100 Tablets/ 1 Tablet Per Packet Pull To Open This Package is for Households without Young Children. • Temporary relief from pain, fever and inflammation • Soothes muscle aches and minor arthritis pain Compare active ingredient to: Advil® Registered Trademark of Pfizer Consumer Healthcare Tamper Evident Unit Dose Packets