Help I Have an Aching Body: Package Insert and Label Information

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

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. 4New York, NY 10001

www.helpineedhelp.com

achingbodylabel
(click image for full-size original)

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 Type HUMAN OTC DRUG Item Code (Source) NDC:49260-615
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 200 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYDROXYPROPYL CELLULOSE
HYPROMELLOSES
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
STEARIC ACID
TITANIUM DIOXIDE
Product Characteristics
Color white (white) Score no score
Shape ROUND (round) Size 10mm
Flavor Imprint Code 44352
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49260-615-50 50 TABLET (TABLET) in 1 BOTTLE None
2 NDC:49260-615-16 16 TABLET (TABLET) in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075139 07/01/2009
Labeler — Help Remedies, Inc. (050359682)

Revised: 03/2013 Help Remedies, Inc.

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