Ibuprofen Capsules 200 mg

Ibuprofen Capsules 200 mg

Drug Labeling and Warnings

Drug Details

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IBUPROFEN- ibuprofen capsule, liquid filled 
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd

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Ibuprofen Capsules 200 mg

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

  • 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
  • blister
If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning: This product contains an 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 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

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, kidney disease, or asthma
  • you are taking a diuretic

Ask a doctor or pharmacist before use if you are

  • under a doctor's care for any serious conditon
  • 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
  • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

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
  • 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 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. (1-800-222-1222)

Directions

  • do not take more than directed
  • the smallest effective dose should be used
  • 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 1 capsule, 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

  • each capsule contains: potassium 20 mg
  • read all warnings and directions before use. Keep carton.
  • store at 20°-25°C (68°-77°F)
  • avoid excessive heat above 40°C (104°F)

Inactive ingredients

FD&C green #3, gelatin, medium chain triglycerides, polyethylene glycol, potassium hydroxide, purified water, sorbitol sorbitan solution, and white edible ink

Questions or commonts

Call toll free: 1-855-215-8180

PRINCIPAL DISPLAY PANEL

Ibuprofen Capsules 200mg, 20ct

Quantity: 35 Bottles

NDC No.:53345-014-02

MADE IN CHINA

IMPORTANT:

1.Inspect immediately upon receipt.
2.This is a bulk shipment, intended for further processing only.
3.Protect from heat, humidity, and light. Do not refrigerate.

4.Store at 20-25°C (68-77)°F

Ibuprofen Capsules Shipping Label

IBUPROFEN 
ibuprofen capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 53345-014
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
GELATIN (UNII: 2G86QN327L)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
SORBITAN (UNII: 6O92ICV9RU)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Colorgreen (Clear) Scoreno score
ShapeCAPSULE (Oblong) Size18mm
FlavorImprint Code PC16
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 53345-014-0235 in 1 BOX07/13/2017
120 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20656807/13/2017
Labeler - Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd (421293287)
Establishment
NameAddressID/FEIBusiness Operations
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.421293287manufacture(53345-014) , analysis(53345-014)

Revised: 7/2017
 
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd


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