IBUPROFEN- ibuprofen 200mg tablet, film coated

IBUPROFEN by

Drug Labeling and Warnings

IBUPROFEN by is a Otc medication manufactured, distributed, or labeled by ADVANCED FIRST AID, INC., ULTRA SEAL CORPORATION, GRANULES INDIA LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENT IN EACH TABLET- Ibuprofen 200 mg (NSAID)

PURPOSE

pain reliever/fever reducer

INDICATIONS & USAGE

Uses:

temporarily relieves minor aches and pains due to: headache muscular aches backache minor pain of arthritis toothache menstrual cramps common cold temporarily reduces fever

WARNINGS

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 blisters 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 had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing an NSAID [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: if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery

Ask a doctor 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 disease, liver cirrhosis, or kidney disease taken a diuretic reached age 60 or older

Ask a doctor or pharmacist before use if you are: taking any other drug containing an NSAID (prescription or nonprescription) taking a blood thinning (anticoagulant) or steroid drug under a doctor’s care for any serious condition taking any other drug

taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin

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 a doctor if: you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding. 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 the painful area any new symptoms appear

PREGNANCY OR BREAST FEEDING

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.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions:

Adults and children 12 years of age and older:

do not take more than directed the smallest effective dose should be used 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 of age: do not use for children under 12 years of age unless directed by a doctor.

INACTIVE INGREDIENT

Inactive Ingredients: crosscarmellose sodium*, FD& C Blue #2*, FD& C red #40*, FD& C Yellow #6*, hypromellose*, iron oxide red*, lactose monohydrate*, magnesium stearate*, maltodextrin*, medium chain triglycerides*, microcrystalline cellulose*, polydextrose*, polyethylene glycol*, polyvinyl alcohol*, povidone (K-30)*, silicon dioxide, sodium starch glycolate*, starch, stearic acid*, talc*, titanium dioxide, triacetin* *contains one or more of these ingredients

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

IBUPROFEN 
ibuprofen 200mg tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67060-001
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)
POVIDONE K30 (UNII: U725QWY32X)
FERRIC OXIDE RED (UNII: 1K09F3G675)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STEARIC ACID (UNII: 4ELV7Z65AP)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
HYPROMELLOSE 2208 (4000 MPA.S) (UNII: 39J80LT57T)
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	brown	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: 67060-001-68	100 in 1 CARTON	04/09/2015
1		2 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 67060-001-67	250 in 1 CARTON	04/09/2015
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	ANDA079174	04/09/2015

Labeler - ADVANCED FIRST AID, INC. (114477180)

Registrant - ADVANCED FIRST AID, INC. (114477180)

Establishment
Name	Address	ID/FEI	Business Operations
ULTRA SEAL CORPORATION		085752004	pack(67060-001)

Establishment
Name	Address	ID/FEI	Business Operations
GRANULES INDIA LTD		918609236	manufacture(67060-001)