- ACTIVE INGREDIENT
- PURPOSE
-
WARNINGS
Allergy alerts: Ibuprofen may cause a severe allergy reaction, especially in people allergic to aspirin.
Symptoms may include:- asthma (wheezing)
- blisters
- facial swelling
- hives
- rash
- shock
- skin reddening
If an allergic reaction occurs, stop use and seek medical help right away.
Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if you:- are age 60 or older
- have bad stomach ulcers or bleeding problems
- take a blood thinning (anticoagulant) or steroid drug
- take other drug containing prescription NSAID (aspirin, ibuprofen, naproxen, or others)
- have 3 or more alcoholic drinks every day while using this product
- the more or for a longer time than directed
- DO NOT USE
-
ASK DOCTOR/PHARMACIST
Ask a doctor before use if you have
- problems or serious side effects from taking pain relievers or fever reducers
- stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain
- ulcers
- bleeding problems
- high blood pressure
- heart or kidney disease
- taken a diuretics
- reached age 60 or older
Ask a doctor or pharmacist before use if you are- taking any other drugs containg an NSAID (prescription or nonprescription)
- taking a blood thining (anticoagulant) or steriod drug
- under a doctor’s care for any serious condition
- taking aspirin for heart attacks or stroke, because ibuprofen may decrease this benefit of aspirin
- taking any other drug
When using this product- take with food or milk if stomach upset occurs
- long term continuous use may increase the risk of heart attack or stroke
Stop use and ask doctor if- you feel faint, vomit blood, or have bloody or black stools
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- stomach pain or upset gets worse or lasts
- redness or swelling is present in painful area
- any new symptoms appear
- PREGNACNCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- INACTIVE INGREDIENTS
-
QUESTIONS
Directions
- do not take more than directed
- the smallest effective dose should be used
- do not take longer than 10 days, unless directed by a docter
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 information
store between 20-25 0c (68-77 0 F).
- do not use if seal under bottle cap imprinted with” SEALED for YOUR PROTECTION” is broken or missing
-
PRINCIPAL DISPLAY PANEL
Manufactured for:
Marksans Pharma Inc.
Lake Grove, NY11755, USAManufactured by:
Marksans Pharma Ltd.
Verna, Goa-403722, IndiaRepackaged and Distributed by:
Apotheca, Inc.
Phoenix, AZ 85006Repackaged and Distributed for:
RejuviLife
Phoenix, AZ 85015
NDC 12634-518-74
IBUPROFEN
MAXIMUM STRENGTH
WITHOUT A PRESCRIPTION
BROWN COATED TABLETS
Pain Reliver
Fever Reducer
RejuviLife®
24 TABLETS 200MG
-
INGREDIENTS AND APPEARANCE
IBUPROFEN
ibuprofen tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:12634-518(NDC:25000-114) 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 COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FERRIC OXIDE RED (UNII: 1K09F3G675) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color brown Score no score Shape ROUND Size 10mm Flavor Imprint Code 114 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:12634-518-74 24 in 1 BOTTLE 2 NDC:12634-518-01 100 in 1 BOTTLE 3 NDC:12634-518-10 1000 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091239 02/14/2014 Labeler - Apotheca, Inc (051457844) Establishment Name Address ID/FEI Business Operations Apotheca, Inc 051457844 repack(12634-518)