Tri-Legest

Name: Tri-Legest

Tri-Legest Overview

Tri-Legest is a prescription birth control medication used to prevent pregnancy. Tri-Legest may also be taken to treat moderate acne in females who are at least 15 years of age, have started having menstrual periods, are able to use the pill and want the pill for birth control, plan to stay on the pill for at least 6 months, and have not improved with acne medicines that are put on the skin.

Tri-Legest contains two hormones, norethindrone and ethinyl estradiol, which belong to a group of drugs called hormonal contraceptives. These hormones prevent pregnancy by stopping ovulation and by altering cervical mucus and the lining of the uterus to prevent sperm from entering.

This medication comes in tablet form and is taken once daily, with or without food.

Common side effects of Tri-Legest include nausea, breast tenderness, and vaginal bleeding between menstrual periods. 

Manufacturer

  • Barr Laboratories, Inc.

Tri-Legest Drug Class

Tri-Legest is part of the drug class:

  • Combination Progesterone and Estrogen Contraceptives

Principal display panel

Tri-Legest Fe (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets*) Pouch Text

NDC 0555-9032-70

Tri-Legest® Fe

(norethindrone acetate and

ethinyl estradiol tablets, USP

and ferrous fumarate tablets*)

Each cycle pack contains the following:

Each light pink tablet (5) contains 1 mg norethindrone acetate

and 20 mcg ethinyl estradiol.

Each light yellow tablet (7) contains 1 mg norethindrone acetate

and 30 mcg ethinyl estradiol.

Each light blue tablet (9) contains 1 mg norethindrone acetate

and 35 mcg ethinyl estradiol ferrous fumarate

Each brown tablet (7) contains ferrous fumarate 75 mg.

*Ferrous fumarate tablets are not USP for dissolution and assay.

28 DAY REGIMEN

THIS PRODUCT (LIKE ALL ORAL CONTRACEPTIVES) IS INTENDED TO PREVENT PREGNANCY. IT DOES NOT PROTECT AGAINST HIV INFECTION (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES.

Rx only

SHAPING
WOMEN'S HEALTH®

TEVA

Tri-Legest FE  28 DAY
norethindrone acetate and ethinyl estradiol kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0555-9032
Packaging
# Item Code Package Description
1 NDC:0555-9032-70 5 BLISTER PACK in 1 CARTON
1 1 KIT in 1 BLISTER PACK
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1
Part 2
Part 3
Part 4
Part 1 of 4
Tri-Legest FE  28 DAY
norethindrone acetate and ethinyl estradiol tablet
Product Information
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NORETHINDRONE ACETATE (NORETHINDRONE) NORETHINDRONE ACETATE 1 mg
ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 20 ug
Inactive Ingredients
Ingredient Name Strength
CALCIUM STEARATE  
FD&C RED NO. 40  
ALUMINUM OXIDE  
LACTOSE MONOHYDRATE  
CELLULOSE, MICROCRYSTALLINE  
STARCH, CORN  
SODIUM STARCH GLYCOLATE TYPE A POTATO  
Product Characteristics
Color PINK (light pink) Score no score
Shape ROUND Size 6mm
Flavor Imprint Code b;711
Contains     
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076105 10/26/2007
Part 2 of 4
Tri-Legest FE  28 DAY
norethindrone acetate and ethinyl estradiol tablet
Product Information
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NORETHINDRONE ACETATE (NORETHINDRONE) NORETHINDRONE ACETATE 1 mg
ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 30 ug
Inactive Ingredients
Ingredient Name Strength
CALCIUM STEARATE  
D&C YELLOW NO. 10  
ALUMINUM OXIDE  
LACTOSE MONOHYDRATE  
CELLULOSE, MICROCRYSTALLINE  
STARCH, CORN  
SODIUM STARCH GLYCOLATE TYPE A POTATO  
Product Characteristics
Color YELLOW (light yellow) Score no score
Shape ROUND Size 6mm
Flavor Imprint Code b;712
Contains     
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076105 10/26/2007
Part 3 of 4
Tri-Legest FE  28 DAY
norethindrone acetate and ethinyl estradiol tablet
Product Information
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NORETHINDRONE ACETATE (NORETHINDRONE) NORETHINDRONE ACETATE 1 mg
ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 35 ug
Inactive Ingredients
Ingredient Name Strength
CALCIUM STEARATE  
FD&C BLUE NO. 2  
ALUMINUM OXIDE  
LACTOSE MONOHYDRATE  
CELLULOSE, MICROCRYSTALLINE  
STARCH, CORN  
SODIUM STARCH GLYCOLATE TYPE A POTATO  
Product Characteristics
Color BLUE (light blue) Score no score
Shape ROUND Size 6mm
Flavor Imprint Code b;713
Contains     
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076105 10/26/2007
Part 4 of 4
Tri-Legest FE  28 DAY
ferrous fumarate tablet
Product Information
Route of Administration ORAL DEA Schedule     
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE  
FERROUS FUMARATE  
COTTONSEED OIL  
CELLULOSE, MICROCRYSTALLINE  
Product Characteristics
Color BROWN Score no score
Shape ROUND Size 6mm
Flavor Imprint Code b;247
Contains     
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076105 10/26/2007
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076105 10/26/2007
Labeler - Barr Laboratories Inc. (802716563)
Revised: 08/2012   Barr Laboratories Inc.

For the Consumer

Applies to ethinyl estradiol / norethindrone: oral capsule liquid filled, oral tablet, oral tablet chewable

Other dosage forms:

  • oral tablet, oral tablet chewable

Along with its needed effects, ethinyl estradiol / norethindrone may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking ethinyl estradiol / norethindrone:

Incidence not known
  • Abdominal or stomach pain
  • absent, missed, or irregular menstrual periods
  • anxiety
  • change in vision
  • changes in skin color
  • chest pain or discomfort
  • chills
  • clay-colored stools
  • constipation
  • cough
  • dark urine
  • diarrhea
  • dizziness or lightheadedness
  • fainting
  • fast heartbeat
  • fever
  • headache
  • hives or welts
  • itching skin
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • loss of appetite
  • medium to heavy, irregular vaginal bleeding between regular monthly periods, which may require the use of a pad or a tampon
  • nausea and vomiting
  • pain or discomfort in the arms, jaw, back, or neck
  • pain, tenderness, or swelling of the foot or leg
  • pains in the chest, groin, or legs, especially in the calves of the legs
  • pounding in the ears
  • rash
  • redness of the skin
  • severe headaches of sudden onset
  • slow or fast heartbeat
  • sudden loss of coordination or slurred speech
  • sudden onset of shortness of breath for no apparent reason
  • sudden shortness of breath or troubled breathing
  • sweating
  • unusual tiredness or weakness
  • vomiting of blood

Some side effects of ethinyl estradiol / norethindrone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known
  • Abdominal or stomach cramps
  • bloating
  • blotchy spots on the exposed skin
  • breast enlargement or tenderness
  • discouragement
  • feeling sad or empty
  • irritability
  • itching of the vagina or outside genitals
  • loss of interest or pleasure
  • pain during sexual intercourse
  • thick, white curd-like vaginal discharge without odor or with mild odor
  • tiredness
  • trouble concentrating
  • trouble sleeping
  • trouble wearing contact lenses

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