HELP I HAVE AN ACHING BODY- ibuprofen tablet

Help I Have an Aching Body by

Drug Labeling and Warnings

Help I Have an Aching Body by is a Otc medication manufactured, distributed, or labeled by Help Remedies, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

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

*nonsteroidal anti-inflammatory drug

PURPOSE

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

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

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

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)

PREGNANCY OR BREAST FEEDING

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.

DOSAGE & ADMINISTRATION

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

INDICATIONS & USAGE

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.

QUESTIONS

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

www.helpineedhelp.com

PRINCIPAL DISPLAY PANEL

INACTIVE INGREDIENT

Inactive ingredients

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

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	200 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	white (white)	Score	no score
Shape	ROUND (round)	Size	10mm
Flavor		Imprint Code	44352
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49260-615-50	50 in 1 BOTTLE
2	NDC: 49260-615-16	16 in 1 BLISTER PACK

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)