HANDY SOLUTIONS IBUPROFEN- ibuprofen tablet, coated

Handy Solutions Ibuprofen by

Drug Labeling and Warnings

Handy Solutions Ibuprofen by is a Otc medication manufactured, distributed, or labeled by Navajo Manufacturing Company Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients (in each caplet)

Ibuprofen 200 mg

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

Temporarily relieves minor aches, pains and fever associated with: 

 headache  backache  common cold  muscular aches  toothache  menstrual cramps  minor pain of arthritis
Temporarily reduces fever.

Warnings

Allergy Alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
 hives  skin reddening  asthma (wheezing)  facial swelling  rash  shock   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 or fever reducer
 right before or after heart surgery

Ask a doctor before use if you have

 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 or unexpected symptoms occur

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. 

Directions

• do not use more than directed
• the smallest effective dose should be used  

Adults and children 12 years of age and older: Take 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, 2 tablets may be used. Do not exceed 6 tablets in 24 hours, unless directed by a doctor.

Children under 12 years or age: Do not give to children under 12 years of age.

Other information

• Tamper evident. Do not use if packet is torn, cut or opened.
• store at controlled room temperatures 20° to 25°C (68° to 77°F)
• Avoid excessive heat above 40°C (104°F)
• Read all product information before using

Inactive ingredients

carnauba wax*, corn starch, hypromellose, iron oxide red, lactose monohydrate*, magnesium stearate*, microcrystalline cellulose*, polydextrose*, polyethylene glycol, povidone K30*, silicon dioxide, sodium starch glycolate, stearic acid, titanium dioxide, triacetin*
*may contain

Questions or comments?

1-800-525-5097

Package Labeling:

INGREDIENTS AND APPEARANCE

HANDY SOLUTIONS IBUPROFEN 
ibuprofen tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67751-164(NDC:47682-600)
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)
STARCH, CORN (UNII: O8232NY3SJ)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
FERRIC OXIDE RED (UNII: 1K09F3G675)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYDEXTROSE (UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE K30 (UNII: U725QWY32X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	brown	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	44;291
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67751-164-01	1 in 1 CARTON	09/22/2016
1		4 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075010	09/22/2016

Labeler - Navajo Manufacturing Company Inc. (091917799)

Establishment
Name	Address	ID/FEI	Business Operations
Navajo Manufacturing Company Inc.		136941411	relabel(67751-164)