IBUPROFEN 100- ibuprofen tablet, coated IBUPROFEN 250- ibuprofen tablet, coated

IBUPROFEN 250 by

Drug Labeling and Warnings

IBUPROFEN 250 by is a Otc medication manufactured, distributed, or labeled by JHK Inc dba American Safety & First Aid. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts
Active ingredient (In Each Tablets)

Ibuprofen, USP 200 mg (NSAID)

*Nonsteroidal Anti-Inflammatory Drug
Purpose

pain reliever/fever reducer
Use
temporarily relieves fever and minor aches and pains associated with:
- common cold
- backache
- headache
- toothache
- arthritis
- muscular aches
- menstrual cramps
Warnings
Allergy Alert

Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
- hives
- asthma (wheezing)
- facial swelling
- shock
- skin reddening
- rash
- 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 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 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 a history of stomach problems, such as heartburn
- you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
- you are taking a diuretic
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) drug
- under a doctor's care for any serious condition
- 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 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
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 DEFINITELY 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. In case of overdose, get medical help or contact a Poison Control Center right away.
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 doctor (see Warnings)
Adults: 1 tablet every 4 to 6 hours while symptoms occur; if pain or fever does not respond to 1 tablet, 2 tablets may be used, but do not exceed 6 tablets in 24 hours unless directed by a doctor.

Children under 12 years: Ask a doctor.
Other Information
- do not use if packet is opened or torn
- Store at 20-25°C (68-77°F) avoid excessive heat above 40°C (104°F)
Inactive Ingredients

crosscarmellose sodium1, FD& C Blue #21, FD& C red #401, FD& C Yellow #61, hypromellose1, iron oxide red1, lactose monohydrate1, magnesium stearate1, maltodextrin1, medium chain triglycerides1, microcrystalline cellulose1, polydextrose1, polyethylene glycol1, polyvinyl alcohol1, povidone (K-30)1, silicon dioxide, sodium starch glycolate1, starch, stearic acid1, talc1, titanium dioxide, triacetin1,

1 contains one or more of these ingredients

Questions?

1-866-651-3660 Monday-Friday

8:00am-5:00pm EST

PRINCIPAL DISPLAY PANEL - 100 Tablet Packet Box

This product is not manufactured or distributed by
Pfizer Consumer Healthcare
Owner of the registered trademark Advil®.

Product #1102

Ibuprofen

Pain Reliever/Fever Reducer

Active ingredient:
Ibuprofen

Temporary relief from pain, fever and inflammation
Soothes muscles aches and minor arthritis pain
Non-drowsy, aspirin-free formula

These quality comfort tablets are formulated and packaged for use in the
workplace and meet ANSI Z308.1-2015 standards. They are sealed in
tamper-evident packets for safety and convenience.

100 Tablets 2 Tablets Per Packet

PRINCIPAL DISPLAY PANEL - 100 Tablet Packet Box

PRINCIPAL DISPLAY PANEL - 250 Tablet Packet Box

Product #1104

Ibuprofen

Pain Reliever/Fever Reducer

Active ingredient:
Ibuprofen

Temporary relief from pain, fever and inflammation
Soothes muscles aches and minor arthritis pain
Non-drowsy, aspirin-free formula

These quality comfort tablets are formulated and packaged for use in the
workplace and meet ANSI Z308.1-2015 standards. They are sealed in
tamper-evident packets for safety and convenience.

250 Tablets 2 Tablets Per Packet

PRINCIPAL DISPLAY PANEL - 250 Tablet Packet Box

INGREDIENTS AND APPEARANCE

IBUPROFEN 100
ibuprofen tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73598-1102
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	200 mg

Ingredient Name	Strength
Inactive Ingredients
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
FERRIC OXIDE RED (UNII: 1K09F3G675)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYDEXTROSE (UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
POVIDONE K30 (UNII: U725QWY32X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	BROWN	Score	2 pieces
Shape	ROUND	Size	10mm
Flavor		Imprint Code	G2
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 73598-1102-1	50 in 1 BOX	02/02/2000
1		2 in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA072096	02/02/2000

IBUPROFEN 250
ibuprofen tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73598-1104
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	200 mg

Ingredient Name	Strength
Inactive Ingredients
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
FERRIC OXIDE RED (UNII: 1K09F3G675)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYDEXTROSE (UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
POVIDONE K30 (UNII: U725QWY32X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	BROWN	Score	2 pieces
Shape	ROUND	Size	10mm
Flavor		Imprint Code	G2
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 73598-1104-1	125 in 1 BOX	02/02/2000
1		2 in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA072096	02/02/2000

Labeler - JHK Inc dba American Safety & First Aid (867236309)