Ibuprofen Pain Reliever/ Fever Reducer (Ibuprofen 200 Mg) Tablet [Chain Drug Consortium] -

IBUPROFEN PAIN RELIEVER/ FEVER REDUCER (IBUPROFEN 200 MG) TABLET [CHAIN DRUG CONSORTIUM]
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NDC	68016-030-14, 68016-030-16
Set ID	17331594-e332-4ada-9b6b-3805d92f0e98
Category	HUMAN OTC DRUG LABEL
Packager	Chain Drug Consortium
Generic Name
Product Class
Product Number
Application Number	ANDA019355

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Active ingredient

Ibuprofen USP, 200mg (NSAID)**
**nonsteroidal anti-inflammatory drug
Purpose

Pain reliever/fever reducer
Uses

temporarily relieves minor aches and pains due to: ■ headache ■ muscular aches ■ minor pain of arthritis ■ toothache ■ backache ■ the common cold ■ menstrual cramps ■ temporarily reduces fever
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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chances are 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

■ you have problems or serious side effects from taking pain relievers or fever reducers ■ the 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 have asthma ■ you are taking a diuretic

Ask a doctor or pharmacist before use if you are

■ taking aspirin to prevent heart attack or stroke, because ibuprofen may decrease this benefit of aspirin 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 occursthe 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

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 (1-800-222-1222).
Directions

■ do not take more than directed
■ the smallest effective dose should be used
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 °C (68-77° F). ■ Read all warnings and directions before use Do not use if
seal under bottle cap is broken or missing.
Inactive Ingredients

Colloidal silicon dioxide, corn starch, FD&C Yellow #6 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide and triacetin
Questions or Comments?

Call 1-888-952-0050
Monday through Friday 9AM – 5PM EST
Package/Label Principal Display Panel

$Z:\SPL-OTC Mono\PV\Ibuprofen tablet Orange\LB1049.jpg$

INGREDIENTS AND APPEARANCE

IBUPROFEN PAIN RELIEVER/ FEVER REDUCER
ibuprofen 200 mg tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68016-030
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	ORANGE	Score	no score
Shape	ROUND	Size	17mm
Flavor		Imprint Code	IBU200
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:68016-030-14	50 in 1 CARTON; Type 0: Not a Combination Product	12/30/2014
2	NDC:68016-030-16	100 in 1 CARTON; Type 0: Not a Combination Product	12/30/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA019355	12/30/2014

Labeler - Chain Drug Consortium (101668460)

Registrant - Chain Drug Consortium (101668460)

Name	Address	ID/FEI	Business Operations
Establishment
Allegiant Health		079501930	LABEL(68016-030) , MANUFACTURE(68016-030) , PACK(68016-030) , RELABEL(68016-030) , REPACK(68016-030)

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Medic

IBUPROFEN PAIN RELIEVER/ FEVER REDUCER (IBUPROFEN 200 MG) TABLET [CHAIN DRUG CONSORTIUM]

Allergy alert

Stomach bleeding warning

Do not use

Ask a doctor before use if

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding

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