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

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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 INGREDIENTS

D&C Yellow # 10, 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. 08-2011

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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IBUPROFEN PAIN RELIEVER/FEVER REDUCER 
ibuprofen capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65162-770
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GELATIN (UNII: 2G86QN327L)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
WATER (UNII: 059QF0KO0R)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorturquoiseScoreno score
ShapeCAPSULESize18mm
FlavorImprint Code A;77
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65162-770-021 in 1 CARTON12/23/2011
120 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:65162-770-691 in 1 CARTON12/23/2011
280 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:65162-770-50500 in 1 BOTTLE; Type 0: Not a Combination Product12/23/2011
4NDC:65162-770-111000 in 1 BOTTLE; Type 0: Not a Combination Product12/23/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20230012/23/2011
Labeler - Amneal Pharmaceuticals LLC (123797875)
Establishment
NameAddressID/FEIBusiness Operations
Amneal Pharmaceuticals of New York, LLC123797875analysis(65162-770, 65162-770) , label(65162-770, 65162-770) , manufacture(65162-770, 65162-770) , pack(65162-770, 65162-770)

Revised: 12/2023
Document Id: 78419e75-265c-43f9-9206-088213ff0115
Set id: 5f27dd3f-c735-417b-95e6-26dc5aae5a7a
Version: 12
Effective Time: 20231219
 
Amneal Pharmaceuticals LLC