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ASHLYNA- levonorgestrel and ethinyl estradiol and ethinyl estradiol kit


  1. Patient Information
  2. Manufactured By:
  3. Manufactured For:

Patient Information 

SeeFDA-Approved Patient Labeling

Counsel patients that cigarette smoking increases the risk of serious cardiovascular events from COC use, and that women who are over 35 years old and smoke should not use COCs.
Counsel patients that this product does not protect against HIV-infection (AIDS) and other sexually transmitted diseases.
Counsel patients on Warnings and Precautions associated with COCs.
Counsel patients to take one tablet daily by mouth at the same time every day. Instruct patients what to do in the event pills are missed. SeeWHAT TO DO IF YOU MISS PILLSsection of FDA-Approved Patient Labeling.
Counsel patients to use a back-up or alternative method of contraception when enzyme inducers are used with COCs.
Counsel patients who are breastfeeding or who desire to breastfeed that COCs may reduce breast milk production. This is less likely to occur if breastfeeding is well established.
Counsel any patient who starts COCs postpartum, and who has not yet had a period, to use an additional method of contraception until she has taken a blue tablet for 7 consecutive days.
Counsel patients that amenorrhea may occur. Pregnancy should be considered in the event of amenorrhea, and should be ruled out if amenorrhea is associated with symptoms of pregnancy, such as morning sickness or unusual breast tenderness.

Manufactured By: 

Glenmark Pharmaceuticals Ltd.
Colvale-Bardez, Goa 403 513, India

Manufactured For: 

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Glenmark Pharmaceuticals Inc., USA
Mahwah, NJ 07430

Questions? 1 (888)721-7115
www.glenmarkpharma.com/usa

September 2017



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