NDC | 47682-610-33, 47682-610-48, 47682-610-99 |
Set ID | 2923c4a3-f994-67a7-e054-00144ff8d46c |
Category | HUMAN OTC DRUG LABEL |
Packager | Unifirst First Aid Corporation |
Generic Name | |
Product Class | |
Product Number | |
Application Number | ANDA075010 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- SPL UNCLASSIFIED SECTION
-
SPL UNCLASSIFIED SECTION
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
- SPL UNCLASSIFIED SECTION
- 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
-
Green Guard Ibupro Relief Label
Ibupro relief ™
Compare active ingredient to Advil ®
Green Guard ®
Pull To Open
Tire Para Abrir
Ibuprofen 200 mg/Ibuprofeno 200 mg
Pain Reliever/Fever Reducer (NSAID)
Alivia el Dolor/ Reduce la Fiebre (AINE)
Advil ® is a Registered Trademark of Pfizer Consumer Healthcare
125 packets of 2 Tablets
250 Tablets
Order# 2251
Distributed by Green Guard ®
St. Louis, MO 63045
-
INGREDIENTS AND APPEARANCE
GREEN GUARD IBUPRO RELIEF
ibuprofen tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:47682-610 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) FERRIC OXIDE RED (UNII: 1K09F3G675) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) STARCH, CORN (UNII: O8232NY3SJ) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE (UNII: J2B2A4N98G) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYDEXTROSE (UNII: VH2XOU12IE) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) CARNAUBA WAX (UNII: R12CBM0EIZ) 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:47682-610-33 50 in 1 BOX 01/26/2017 1 NDC:47682-610-99 2 in 1 PACKET; Type 0: Not a Combination Product 2 NDC:47682-610-48 125 in 1 BOX 01/26/2017 2 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 02/01/2016 Labeler - Unifirst First Aid Corporation (832947092)