Label: UNISHIELD IBUPROFEN- ibuprofen tablet, coated
- NDC Code(s): 49314-0993-3, 49314-1003-3
- Packager: Unishield
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 17, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
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 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
-
ASK DOCTOR
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
- ASK DOCTOR/PHARMACIST
- WHEN USING
-
STOP USE
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
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
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
-
INACTIVE INGREDIENT
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
- QUESTIONS
-
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
-
INGREDIENTS AND APPEARANCE
UNISHIELD IBUPROFEN
ibuprofen tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49314-1003 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg Inactive Ingredients Ingredient Name Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) STARCH, CORN (UNII: O8232NY3SJ) FERRIC OXIDE RED (UNII: 1K09F3G675) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) POVIDONE (UNII: FZ989GH94E) TALC (UNII: 7SEV7J4R1U) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) Product Characteristics Color brown (Reddish) Score no score Shape ROUND Size 10mm Flavor Imprint Code G;2 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49314-1003-3 50 in 1 BOX 03/01/2021 1 2 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA079174 03/01/2021 UNISHIELD IBUPROFEN
ibuprofen tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49314-0993 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg Inactive Ingredients Ingredient Name Strength HYPROMELLOSES (UNII: 3NXW29V3WO) POLYDEXTROSE (UNII: VH2XOU12IE) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CARNAUBA WAX (UNII: R12CBM0EIZ) STARCH, CORN (UNII: O8232NY3SJ) FERRIC OXIDE RED (UNII: 1K09F3G675) STEARIC ACID (UNII: 4ELV7Z65AP) LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color brown Score no score Shape ROUND Size 10mm Flavor Imprint Code 44;291 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49314-0993-3 50 in 1 BOX 03/01/2021 1 2 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075010 03/01/2021 Labeler - Unishield (790677053) Registrant - Unifirst First Aid Corporation (832947092)