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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:65162-356
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
GELATIN 
POLYETHYLENE GLYCOL 400 
WATER 
POTASSIUM HYDROXIDE 
SORBITOL 
Product Characteristics
ColorBLUEScoreno score
ShapeCAPSULESize18mm
FlavorImprint Code A356
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65162-356-021 in 1 CARTON
120 in 1 BOTTLE
2NDC:65162-356-691 in 1 CARTON
280 in 1 BOTTLE
3NDC:65162-356-50500 in 1 BOTTLE
4NDC:65162-356-111000 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20230003/29/2013
Labeler - Amneal Pharmaceuticals (123797875)
Registrant - Amneal Pharmaceuticals (123797875)
Establishment
NameAddressID/FEIBusiness Operations
Amneal Pharmaceuticals831227777ANALYSIS(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