IBUPROFEN- ibuprofen capsule, liquid filled 
XLCare Pharmaceuticals, Inc

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Active ingredient

(in each capsule)

Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*
(present as the free acid and potassium salt)

*nonsteroidal anti-inflammatory drug

PURPOSE

Pain reliever/Fever reducer

Uses

     o headache
     o toothache
     o backache
     o menstrual cramps
     o the common cold
     o muscular aches
     o minor pain of arthritis

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 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

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

      .  feel faint

      .  vomit blood

      .  have bloody or black stools

      .  have stomach pain that does not get better

      .  chest pain

      .  trouble breathing

      .  slurred speech

      .  leg swelling

      .  weakness in one part or side of body

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.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

 adults and children 12 years and over:
  • take 1 capsule every 4 to 6 hours while symptoms persist
  • if pain or fever does not respond to 1capsule, 2 capsules may be used
  • do not exceed 6 capsules in 24 hours, unless directed by a doctor
 children under 12 years:
  •  ask a doctor

Other information

Inactive ingredients

FD&C blue no. 1, FD&C yellow no. 6, gelatin, lecithin (soybean), medium-chain triglycerides, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitol sorbitan.

Questions or comments?

call 1-866-495-1995

NDC 72865-132-16

Ibuprofen Capsules, 200mg

Pain Reliever/ Fever Reducer

(NSAID)

200mg, 160 SOFTGELS

Liquid-Filled Capsules

200 mg capsules-160 count

IBUPROFEN 
ibuprofen capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72865-132
Route of AdministrationORAL, ORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SORBITAN (UNII: 6O92ICV9RU)  
Product Characteristics
ColorGREENScoreno score
ShapeOVALSize20mm
FlavorImprint Code AT146
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72865-132-2020 in 1 BOTTLE; Type 0: Not a Combination Product03/09/2020
2NDC:72865-132-4040 in 1 BOTTLE; Type 0: Not a Combination Product03/09/2020
3NDC:72865-132-8080 in 1 BOTTLE; Type 0: Not a Combination Product03/09/2020
4NDC:72865-132-16160 in 1 BOTTLE; Type 0: Not a Combination Product03/09/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20699903/09/2020
Labeler - XLCare Pharmaceuticals, Inc (080991142)

Revised: 1/2020
Document Id: 0de44491-e307-43f6-8629-024173bc7d5d
Set id: 8fbc30d3-149d-4369-aaf4-6019cff9760d
Version: 1
Effective Time: 20200106
 
XLCare Pharmaceuticals, Inc