FDA Label for Help I Have An Aching Body
View Indications, Usage & Precautions
Help I Have An Aching Body Product Label
The following document was submitted to the FDA by the labeler of this product Help Remedies, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active Ingredient..................................................Purpose
(in each tablet)
Ibuprofen 200 mg (NSAID)*.....................................Pain reliever/ Fever reducer
*nonsteroidal anti-inflammatory drug
Otc - 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 andseek 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 lastsmore 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 • stomachproblems that last or come back, such as heartburn, upset stomach, or stomach pain • bleeding problems • ulcers • high bloodpressure • 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.
Otc - 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
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a PoisonControl Center right away. (1-800-222-1222)
Otc - 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.
Otc - Questions
Distributed by Help Remedies,
57 W. 28th St. Fl. 4
New York, NY 10001
www.helpineedhelp.com
Package Label.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.
* Please review the disclaimer below.