设为首页 加入收藏

TOP

Motrin IB(Ibuprofen Tablets USP, 200mg)
2017-08-28 06:58:22 来源: 作者: 【 】 浏览:523次 评论:0

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each caplet)

Ibuprofen 200 mg (NSAID)1

 

1.nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

  • temporarily relieves minor aches and pains due to:
    • headache
    • muscular aches
    • minor pain of arthritis
    • toothache
    • backache
    • the common cold
    • menstrual cramps
  • 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

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:

  • 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

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

  • you have problems or serious side effects from taking pain relievers or fever reducers
  • the stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • you have asthma
  • you are taking a diuretic

Ask a doctor or pharmacist before use if you are
  • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • under a doctor's care for any serious condition
  • 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 older
  • take 1 caplet every 4 to 6 hours while symptoms persist
  • if pain or fever does not respond to 1 caplet, 2 caplets may be used
  • do not exceed 6 caplets in 24 hours, unless directed by a doctor
children under 12 years
  • ask a doctor

Other information

  • store between 20-25°C (68-77°F)
  • do not use if neck wrap or foil inner seal imprinted "SAFETY SEAL®" is broken or missing
  • see end panel for lot number and expiration date

Inactive ingredients

carnauba wax, colloidal silicon dioxide, corn starch, FD&C yellow no. 6, hypromellose, iron oxide, magnesium stearate, polydextrose, polyethylene glycol, pregelatinized starch, propylene glycol, shellac, stearic acid, titanium dioxide

Questions or comments?

Call 1-877-895-3665: weekdays 8:00 AM to 8:00 PM EST

PRINCIPAL DISPLAY PANEL

NDC 50580-110-38

Motrin® IB
Ibuprofen Tablets USP, 200 mg
Pain Reliever / Fever Reducer (NSAID)

300 Coated Caplets*

*Capsule-Shaped Tablets

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

 

MOTRIN IB  ibuprofen tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50580-110
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Ibuprofen (UNII: WK2XYI10QM) (Ibuprofen - UNII:WK2XYI10QM) Ibuprofen 200 mg
Inactive Ingredients
Ingredient Name Strength
carnauba wax (UNII: R12CBM0EIZ)  
silicon dioxide (UNII: ETJ7Z6XBU4)  
starch, corn (UNII: O8232NY3SJ)  
FD&C yellow no. 6 (UNII: H77VEI93A8)  
hypromellose, unspecified (UNII: 3NXW29V3WO)  
ferrosoferric oxide (UNII: XM0M87F357)  
magnesium stearate (UNII: 70097M6I30)  
polydextrose (UNII: VH2XOU12IE)  
polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A)  
propylene glycol (UNII: 6DC9Q167V3)  
shellac (UNII: 46N107B71O)  
stearic acid (UNII: 4ELV7Z65AP)  
titanium dioxide (UNII: 15FIX9V2JP)  
Product Characteristics
Color ORANGE Score no score
Shape OVAL Size 16mm
Flavor   Imprint Code Motrin;IB
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50580-110-01 1 in 1 CARTON 08/01/2000 04/05/2015
1   100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product    
2 NDC:50580-110-02 1 in 1 CARTON 08/01/2000  
2   50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product    
3 NDC:50580-110-07 1 in 1 CARTON 04/16/2013  
3   50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product    
4 NDC:50580-110-09 1 in 1 CARTON 08/01/2000  
4   165 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product    
5 NDC:50580-110-10 1 in 1 CARTON 08/01/2000  
5   100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product    
6 NDC:50580-110-19 2 in 1 POUCH; Type 0: Not a Combination Product 08/01/2000  
7 NDC:50580-110-38 1 in 1 CARTON 08/01/2000  
7   300 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product    
8 NDC:50580-110-51 1 in 1 CARTON 08/01/2000  
8   500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product    
9 NDC:50580-110-52 50 in 1 TRAY 08/01/2000  
9 NDC:50580-110-19 2 in 1 POUCH; Type 0: Not a Combination Product    
10 NDC:50580-110-60 1 in 1 CARTON 08/01/2000  
10   60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product    
11 NDC:50580-110-62 225 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/01/2000  
12 NDC:50580-110-75 1 in 1 CARTON 08/01/2000  
12   150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product    
13 NDC:50580-110-76 1 in 1 CARTON 08/01/2000  
13   75 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product    
14 NDC:50580-110-95 1 in 1 CARTON 08/01/2000  
14   125 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product    
 
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019012 08/01/2000
以下是“全球医药”详细资料
Tags: 责任编辑:admin
】【打印繁体】【投稿】【收藏】 【推荐】【举报】【评论】 【关闭】 【返回顶部
分享到QQ空间
分享到: 
上一篇Motrin IB(Ibuprofen Tablets US.. 下一篇JAKAFI(ruxolitinib phosphate ta..

相关栏目

最新文章

图片主题

热门文章

推荐文章

相关文章

广告位