FDA Label for Sound Body Ibuprofen
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH SOFTGEL)
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Sound Body Ibuprofen Product Label
The following document was submitted to the FDA by the labeler of this product Allegiant Health. 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.
Active Ingredient (In Each Softgel)
Solubilized ibuprofen equal to 200mg ibuprofen (NSAID)*
(present as the free acid and potassium salt)
*nonsteroidal anti-inflammatory drug
Purpose
Pain reliever/fever reducer
Uses
temporarily relieves minor aches and pains due to:
- headache
- toothache
- backache
- menstrual cramps
- the common cold
- muscular aches
- minor pain of arthritis
- temporarily reduces fever
Warnings
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
- hives
- facial swelling
- asthma (wheezing)
- shock
- skin reddening
- rash
- blisters
- are age 60 or older
- have had stomach ulcers or bleeding problems
- take a blood thinning (anticoagulant) or steroid drug
- take other drugs containing prescription or nonprescription NSAIDs (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
If an allergic reaction occurs, stop use and seek medical help right away.
Stomach bleeding warning: This product contains an nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you:
Heart attack and stroke warning: NSAIDs, except aspirin increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.
Do Not Use
- if you have ever had an allergic reaction to any other pain reliever/fever reducer
- right before or after heart surgery
Ask A Doctor Before Use If
- stomach bleeding warning applies to you
- you have problems or serious side effects from taking pain relievers or fever reducers
- you have a history of stomach problems, such as heartburn
- you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
- you are taking a diuretic
Ask A Doctor Or Pharmacist Before Use If You Are
- under a doctor’s care for any serious condition
- taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
- taking any other drug
When Using This Product
- take with food or milk if stomach upset occurs
Stop Use And Ask A Doctor If
you experience any of the following signs of stomach bleeding:
- feel faint
- vomit blood
- have bloody or black stools
- have stomach pain that does not get better
- chest pain
- trouble breathing
- weakness in one part or side of body
- slurred speech
- leg swelling
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present in the painful area
- any new symptoms appear
you have symptoms of heart problems or stroke:
If Pregnant Or Breast-Feeding
If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium 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.
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 (1-800-222-1222) right away.
Directions
- do not take more than directed
- the smallest effective dose should be used
- take 1 softgel every 4 to 6 hours while symptoms persist
- if pain or fever does not respond to 1 softgel, 2 softgels may be used
- do not exceed 6 softgels in 24 hours unless directed by a doctor
Adults and children 12 years and older:
Children under 12 years: ask a doctor
Other Information
- each softgel contains: potassium 20mg
- store between 20-25 °C (68-77° F)
- Read all warnings and directions before use
- Do not use if seal under bottle cap is broken or missing.
Inactive Ingredients
ammonium hydroxide, FD&C green #3 aluminum lake, gelatin, iron oxide black, medium chain triglycerides, polyethylene glycol, propylene glycol, potassium hydroxide, purified water, shellac, sorbitol sorbitan, sorbitan monooleate
Questions Or Comments?
Call 1-888-952-0050
Monday through Friday 9AM - 5PM EST.
Principal Display Panel
SOUNDBODY™
Compare to the active ingredient in Advil® Liqui-Gels®**
Ibuprofen
See New Warnings Information
Pain Reliever/Fever Reducer (NSAID)
40 Liquid Filled Capsules - 200 mg
(softgel image) Actual Size
**This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Advil® Liqui-Gels®.
Distributed by: Allegiant Health
Deer Park, NY 11729
V#5003620 PRODUCT OF INDIA ITEM#FP0647
LB1297
R0617
* Please review the disclaimer below.