VALUMEDS IBUPROFEN- ibuprofen tablet, film coated

VALUMEDS IBUPROFEN by

Drug Labeling and Warnings

VALUMEDS IBUPROFEN by is a Otc medication manufactured, distributed, or labeled by SPIRIT PHARMACEUTICALS LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient (in each tablet)

Ibuprofen 200 mg (NSAID)

Purpose

Pain reliever/fever reducer

Uses

• temporarily relieves minor aches and pains due to:
• headache
• toothache
• backache
• menstrual cramps
• the common cold
• muscular aches
• minor pain of arthritis
• temporarily reduces fever

WARNINGS

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 a nonsteroidal anti-inflammatory drug (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

• the stomach bleeding warning applies to you
• you have problems or serious side effects from taking pain relievers or fever reducers
• you have stomach problems, such as heartburn
• you have high blood pressure, heart disease, liver cirrhosis, kidney disease or asthma
• you are taking a diuretic

Ask a doctor or pharmacist before use if you are

• under a doctor's care for any serious condition
• taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
• 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
• stomach pain or upset gets worse or lasts
• redness or swelling is present in the painful area
• any new symptoms appear

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.

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 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 over: 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: ask a doctor

Other information

• read all warnings and directions before use
• store between 20°-25°C (68°-77°F)
• avoid excessive heat above 40°C (104°F)

Inactive ingredients

Colloidal silicon dioxide, croscarmellose sodium, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide.

Questions or comments?

1-888-333-9792

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Distributed By

Spirit Pharmaceuticals, LLC

Ronkonkoma, NY 11779

PRINCIPAL DISPLAY PANEL- 200 mg 100 ct Bottle

VALUMEDS
*Compare to the active ingredient in Advil®
IBUPROFEN
TABLETS USP,200MG
PAIN RELEIVER/

FEVER REDUCER

(NSAID)
100
TABLETS
(COATED BROWN)

INGREDIENTS AND APPEARANCE

VALUMEDS IBUPROFEN 
ibuprofen tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68210-0800
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	brown	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	114
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68210-0800-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	05/19/2017
2	NDC: 68210-0800-4	1 in 1 CARTON	04/11/2018
2		40 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 68210-0800-3	1 in 1 CARTON	04/11/2018
3		30 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA091239	05/19/2017

Labeler - SPIRIT PHARMACEUTICALS LLC (179621011)

Establishment
Name	Address	ID/FEI	Business Operations
MARKSANS PHARMA LTD		925822975	manufacture(68210-0800)