IBUPROFEN PAIN RELIEVER/FEVER REDUCER- ibuprofen capsule, liquid filled 
Amneal Pharmaceuticals

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Ibuprofen Capsules, liquid filled, 200 mg

OTC - 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

OTC - PURPOSE

Pain reliever/Fever reducer

INDICATIONS AND USAGE

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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you:

OTC - DO NOT USE

Do not use

OTC - ASK DOCTOR

Ask a doctor before use if

OTC - ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are

OTC - WHEN USING

When using this product

OTC - STOP USE

Stop use and ask a doctor if

OTC - PREGNANCY OR BREAST FEEDING

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.

OTC - KEEP OUT OF REACH OF CHILDREN

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.

DOSAGE AND ADMINISTRATION

DIRECTIONS

OTHER INFORMATION

INACTIVE INGREDIENT

FD&C Blue # 1, gelatin, polyethylene glycol, potassium hydroxide, purified water, sorbitol

OTC – QUESTIONS OR COMMENTS?

Call 1-877-835-5472 Monday through Friday 9AM - 5PM EST

READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION

Do Not Use if printed foil under cap is broken or missing.

Distributed by:  Amneal Pharmaceuticals

Glasgow, KY  42141

Rev. 03-2012

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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IBUPROFEN  PAIN RELIEVER/FEVER REDUCER
ibuprofen capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:65162-356
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GELATIN (UNII: 2G86QN327L)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
WATER (UNII: 059QF0KO0R)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
Color BLUE Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code A356
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:65162-356-02 1 in 1 CARTON
1 20 in 1 BOTTLE
2 NDC:65162-356-69 1 in 1 CARTON
2 80 in 1 BOTTLE
3 NDC:65162-356-50 500 in 1 BOTTLE
4 NDC:65162-356-11 1000 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202300 03/29/2013
Labeler - Amneal Pharmaceuticals (123797875)
Registrant - Amneal Pharmaceuticals (123797875)
Establishment
Name Address ID/FEI Business Operations
Amneal Pharmaceuticals 831227777 ANALYSIS(65162-356) , MANUFACTURE(65162-356) , LABEL(65162-356) , PACK(65162-356)

Revised: 11/2012
Document Id: bff016c0-424c-4fef-b2de-01412562470b
Set id: 877440fc-3afb-4123-a2e6-5cb48c74413c
Version: 2
Effective Time: 20121121
 
Amneal Pharmaceuticals