NDC | 70005-009-02, 70005-009-25, 70005-009-50 |
Set ID | 16b751a9-2f33-4303-b75f-ca0c012a212d |
Category | HUMAN OTC DRUG LABEL |
Packager | We Care Distributor Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART343 |
- Active ingredient(in each tablet)
- Purpose
- Uses
-
Warnings
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
- hives
- facial swelling
- asthma (wheezing)
- shock
- skin reddening
- rash
- 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
Do 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 before use if
- stomach bleeding warning applies to you
- you have problems or serious side effects from taking pain relievers or fever reducers
- you have a history of stomach problems, such as heartburn
- you have high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma
- you are taking a diuretic
Ask a doctor or pharmacist before use if you are
- under a doctor’s care for any serious condition
- taking aspirin for heart attack 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
- the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
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
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present in the painful area
- any new symptoms appear
- hives
-
DOSAGE & ADMINISTRATION
- do not take more than directed
- the smallest effective dose should be used
- adults and children 12 years and over: 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
- Inactive ingredients
- Questions or Comments
-
Principal Display Panel
NDC 70005-009-25
SEE NEW WARNINGS AND DIRECTIONS
We Care
For Good Health
COMPARE TO ACTIVE INGREDIENT IN Advil®* CAPLETS
TO OPEN PUSH IN TAB AND PULL OUT
Ibuprofen 200 mg
Pain Reliever/Fever Reducer (NSAID)
- Headache
- Toothache
- Minor Pain of Arthritis
- Fever
- Muscularache
- Menstrual Cramps
Ibuprofen
*This product is not manufactured or distributed by Pfizer Healthcare, owner of the registered trademark of Advil®* tablets.
25 Pouches of 2 Coated Tablets
-
INGREDIENTS AND APPEARANCE
FAST PAIN RELIEF
ibuprofen tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70005-009 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) 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 red Score no score Shape ROUND Size 10mm Flavor Imprint Code G2 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70005-009-02 4 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:70005-009-25 25 in 1 CARTON 2 2 in 1 POUCH; Type 0: Not a Combination Product 3 NDC:70005-009-50 50 in 1 CARTON 3 2 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 12/02/2015 Labeler - We Care Distributor Inc. (079832998) Establishment Name Address ID/FEI Business Operations Granules India Limited 918609236 manufacture(70005-009)