Medication Guide App

Help I Have an Aching Body

Dosage form: tablet
Ingredients: IBUPROFEN 200mg
Labeler: Help Remedies, Inc.
NDC Code: 49260-615

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

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 AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
HYDROXYPROPYL CELLULOSE 
HYPROMELLOSES 
CELLULOSE, MICROCRYSTALLINE 
STARCH, CORN 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
Colorwhite (white) Scoreno score
ShapeROUND (round) Size10mm
FlavorImprint Code44352
Contains    
Packaging
#Item CodePackage Description
1NDC:49260-615-5050 TABLET (TABLET) in 1 BOTTLE
2NDC:49260-615-1616 TABLET (TABLET) 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: 03/2013
 
Help Remedies, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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