SOUND BODY IBUPROFEN- ibuprofen 200 mg capsule, liquid filled 
Allegiant Health

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SoundBody Ibuprofen 200mg

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:

Warnings

Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

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
  •  

you have symptoms of heart problems or stroke:

  • 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

If pregnant or breast-feeding

ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in 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.

 In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Adults and children 12 years and older:

Children under 12 years: ask a doctor

Other information

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

Ibuprofen

Ibuprofen

SOUND BODY IBUPROFEN 
ibuprofen 200 mg capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-914
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
AMMONIA (UNII: 5138Q19F1X)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
GELATIN (UNII: 2G86QN327L)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
WATER (UNII: 059QF0KO0R)  
SHELLAC (UNII: 46N107B71O)  
SORBITOL MONOOLEATE (UNII: 658271J00C)  
Product Characteristics
Colorgreen (sea green) Scoreno score
ShapeCAPSULESize15mm
FlavorImprint Code 133
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69168-914-401 in 1 CARTON12/22/2014
140 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07920512/22/2014
Labeler - Allegiant Health (079501930)

Revised: 11/2017
Document Id: 77768280-6364-4000-9ed6-b71dd594d95f
Set id: 73af6385-3081-49cc-83de-f872a47c31dc
Version: 4
Effective Time: 20171115
 
Allegiant Health