HEALTH SENSE PROVIL- ibuprofen tablet, film coated

HEALTH SENSE PROVIL by

Drug Labeling and Warnings

HEALTH SENSE PROVIL by is a Otc medication manufactured, distributed, or labeled by Prime Marketing, LLC, Geri-Care Pharmaceutical Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each brown tablet)

Ibuprofen USP, 200 mg (NSAID)*
*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

• Temporarily relieves minor aches and pains due to:

-headache

-minor pain of arthritis

-muscular aches

-the common cold

-menstrual cramps

-backache

-toothache

• Temporarily reduces fever

Warnings

Allergy Alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

• shock
• hives
• facial swelling
• asthma (wheezing)
• skin reddening
• rash
• 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

Heart attack and stroke warning: NSAIDs, except
aspirin, increase the risk of heart attack, heart failure,
and stroke. These can be fatal. The risk is higher if you
use more than directed or for longer 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 a history of 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
• 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
• you have symptoms of heart problems or stroke
  - chest pain - trouble breathing - leg swelling
  - slurred speech - weakness in one part or side of body
• pain gets worse or lasts more than 10 days
• redness or swelling is present in the painful area
• fever gets worse or lasts more than 3 days
• any new symptoms occur

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. In case of overdose , get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

• do not use 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 take more than 6 tablets in 24 hours unless directed by a doctor
• children under 12 years: ask a doctor

Other information

• store between 20°-25°C (68°-77°F)
• avoid excessive heat 40°C (104°F) or above
• see end flap for expiration date and lot number

Inactive ingredients

carnauba wax, colloidal silicon dioxide, cellulose, corn starch, hypromellose, lactose, magnesium stearate,
polydextrose, PEG, red iron oxide, sodium starch glycolate, stearic acid, titanium dioxide

Questions or comments?

Call 1-800-540-3765

Package label

NDC: 62107-002-01

Health Sense

Provil

ibuprofen (NSAID)

Pain Reliever

Fever Reducer

100 Tablets USP 200 mg each

INGREDIENTS AND APPEARANCE

HEALTH SENSE PROVIL 
ibuprofen tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62107-002
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)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYDEXTROSE (UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
FERRIC OXIDE RED (UNII: 1K09F3G675)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	brown	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	44291
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62107-002-01	1 in 1 CARTON	01/02/2018
1		100 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	ANDA075010	01/01/2006	01/01/2021

Labeler - Prime Marketing, LLC (071371194)

Registrant - Geri-Care Pharmaceutical Corp (611196254)

Establishment
Name	Address	ID/FEI	Business Operations
Geri-Care Pharmaceutical Corp		611196254	repack(62107-002)