HELP I HAVE AN ACHING BODY - ibuprofen tablet 
Help Remedies, Inc.

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Drug Facts

Active Ingredient..................................................Purpose
(in each tablet)


Ibuprofen 200 mg (NSAID)*.....................................Pain reliever/ Fever reducer

*nonsteroidal anti-inflammatory drug

Use

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


Warnings

 Allergy Alert Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin Symptoms may include:
• shock • hives • facial swelling • asthma (wheezing) • rash • 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.

Stop use and ask a doctor if you feel faint, vomit blood, or have bloody or black stools. These are the 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
more than 10 days • stomach pain or upset gets worse or lasts • redness or swelling is present in the painful area • any new symptoms appear.

Ask a doctor before 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 • bleeding problems • ulcers • high blood
pressure • taken a diuretic • heart or kidney disease • reached age 60 or older.

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


Do not use

• if you have ever had an allergic reaction to any other pain reliever/fever reducer

• right before or after heart surgery


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)

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.


When using this product
• take with food or milk if stomach upset occurs • long term continuous use may increase the risk of a heart attack or stroke.

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 yeas: ask a doctor • do not take more than directed
• the smallest effective dose should be used


Directions
• do not take longer than 10 days, unless directed by a doctor (see Warnings)

Other information
• do not use if packet is torn, cut or opened
• store at controlled room temperature 15-30°C (59-86°F) • avoid excessive heat and humidity
• keep carton. They contain important information.



Distributed by Help Remedies,
57 W. 28th St. Fl. 4
New York, NY 10001

www.helpineedhelp.com

achingbodylabel

Inactive ingredients

colloidal silicon dioxide, croscar-mellose sodium, hydroxypropyl
cellulose, hympromellose, micro-crystalline
cellulose, pregelatinized starch, stearic acid,
titanium dioxide.

HELP I HAVE AN ACHING BODY 
ibuprofen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49260-615
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)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colorwhite (white) Scoreno score
ShapeROUND (round) Size10mm
FlavorImprint Code 44352
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49260-615-5050 in 1 BOTTLE
2NDC:49260-615-1616 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07513907/01/2009
Labeler - Help Remedies, Inc. (050359682)

Revised: 3/2013
Document Id: 62df5f70-2fbf-4620-ab95-09680d33f306
Set id: 845b4bca-fb49-4a98-8ddf-b44320850d84
Version: 2
Effective Time: 20130305
 
Help Remedies, Inc.