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Motrin IB by Navajo Manufacturing Company Inc.

Medically reviewed on September 22, 2016

Dosage form: tablet
Ingredients: IBUPROFEN 200mg
Labeler: Navajo Manufacturing Company Inc.
NDC Code: 67751-165

Motrin IB

Drug Facts

Active ingredient (in each caplet)

Ibuprofen 200 mg (NSAID)*

*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 20-25ºC (68-77ºF)
• see bottom of carton for lot number and expiration date
• do not use if pouch is opened

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 (toll-free) or 215-273-8755 (collect)

Package Labeling:

MOTRIN IB 
ibuprofen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67751-165(NDC:50580-110)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
SILICON DIOXIDE 
STARCH, CORN 
FD&C YELLOW NO. 6 
HYPROMELLOSE, UNSPECIFIED 
FERRIC OXIDE RED 
MAGNESIUM STEARATE 
POLYDEXTROSE 
POLYETHYLENE GLYCOL, UNSPECIFIED 
PROPYLENE GLYCOL 
SHELLAC 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColororangeScoreno score
ShapeOVALSize16mm
FlavorImprint CodeMotrin;IB
Contains    
Packaging
#Item CodePackage Description
1NDC:67751-165-011 POUCH in 1 CARTON
12 TABLET in 1 POUCH
2NDC:67751-165-021 POUCH in 1 CARTON
24 TABLET in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01901209/22/2016
Labeler - Navajo Manufacturing Company Inc. (091917799)

 
Navajo Manufacturing Company Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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