THERAFLEX ADVANCE (ibuprofen, glucosamine sulfate, and chondroitin sulfate- bovine tablet

Theraflex Advance by

Drug Labeling and Warnings

Theraflex Advance by is a Otc medication manufactured, distributed, or labeled by Bayer HealthCare LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each capsule)	Purposes
Glucosamine Sulfate 250 mg	Dietary Supplement
Chondroitin Sulfate 200 mg	Dietary Supplement
Ibuprofen 100 mg	Analgesic

Uses

• temporarily relieves minor aches and pains associated with
  • backache
  • arthritis.

Warnings

Allergy alert

Ibuprofen may cause a severe allergic reaction wich may include:

• hives
• facial swelling
• asthma (wheezing)
• shock.

Alcohol warning

If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take ibuprofen or other pain relieves/fever reducers. Ibuprofen may cause stomach bleeding.

Do not use

• if you have ever had an allergic reaction to any other pain reliever/fever reducer.

When using this product

• take with food or milk if stomach upset occurs.

I f 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.

It is especially important not to use ibuprofen during the last 3 months of pregnancy unless specifically directed to do so by a doctor because it may cause problems in the unborn child or c omplications during delivery.

Directions

Adults

Take 1 capsule every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 capsule, 2 capsules may be used, but do not exceed 6 capsules in 24 hours, unless directed by a doctor. The smallest effective dose should be used.

Children

Do not give this product to children under 12 unless directed by a doctor.

Do not exceed recommended dose.

Other information

• store at room temperature, USP.

Inactive ingredients

Corn Starch, Crospovidone, Gelatin, Magnesium Stearate, Microcrystalline Cellulose, Polyvinylpyrrolidone, Pregelatinized Starch, Silica, Sodium Starch Glycolate, Stearic Acid, Titanium Dioxide, FD&C Blue#1 Lake.

PRINCIPAL DISPLAY PANEL - 60 Capsule Bottle Carton

THERAFLEX™

ADVANCE

60 CAPSULES

Ibuprofen 100 mg

Glucosamine Sulfate 250 mg

Chondroitin Sulfate 200 mg

INGREDIENTS AND APPEARANCE

THERAFLEX ADVANCE 
ibuprofen, glucosamine sulfate, and chondroitin sulfate (bovine) tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61841-152
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	100 mg
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731) (GLUCOSAMINE - UNII:N08U5BOQ1K)	GLUCOSAMINE SULFATE	250 mg
CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z) (CONDOLIASE - UNII:7SI2UZG934)	CHONDROITIN SULFATE (BOVINE)	200 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
CROSPOVIDONE (UNII: 68401960MK)
GELATIN (UNII: 2G86QN327L)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	blue (Blue opaque)	Score	no score
Shape	OVAL	Size	22mm
Flavor		Imprint Code	Theraflex;Advance
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61841-152-72	1 in 1 CARTON	12/11/2014
1		60 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 61841-152-12	1 in 1 CARTON	12/11/2014
2		120 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Export only		12/11/2014

Labeler - Bayer HealthCare LLC. (785159372)