IBUPROFEN PAIN RELIEVER/ FEVER REDUCER- ibuprofen 200 mg tablet 
Chain Drug Consortium

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Drug Facts

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
IBUPROFEN  PAIN RELIEVER/ FEVER REDUCER
ibuprofen 200 mg tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-030
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorORANGEScoreno score
ShapeROUNDSize17mm
FlavorImprint Code IBU200
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-030-1450 in 1 CARTON; Type 0: Not a Combination Product12/30/2014
2NDC:68016-030-16100 in 1 CARTON; Type 0: Not a Combination Product12/30/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA01935512/30/2014
Labeler - Chain Drug Consortium (101668460)
Registrant - Chain Drug Consortium (101668460)
Establishment
NameAddressID/FEIBusiness Operations
Allegiant Health079501930LABEL(68016-030) , MANUFACTURE(68016-030) , PACK(68016-030) , RELABEL(68016-030) , REPACK(68016-030)

Revised: 12/2014
Document Id: 17331594-e332-4ada-9b6b-3805d92f0e98
Set id: 17331594-e332-4ada-9b6b-3805d92f0e98
Version: 1
Effective Time: 20141230
 
Chain Drug Consortium