Manufactured in United States.

Please see Patient Information and Boxed Warning for more details at www.estrogel.com.

EstroGel^® 0.06% is approved by the FDA for use after menopause to reduce moderate to severe hot flashes and to treat moderate to severe menopausal changes in and around the vagina.  If you use EstroGel only to treat your menopausal changes in and around your vagina, talk with your healthcare provider about whether a topical vaginal product would be better for you.

 WHAT IS THE MOST IMPORTANT RISK INFORMATION I SHOULD KNOW ABOUT EstroGel^® (AN ESTROGEN HORMONE)?

Do not start using EstroGel if you have unusual vaginal bleeding, have been diagnosed with a bleeding disorder, currently have or have had certain cancers, had a stroke or heart attack, currently have or have had blood clots, currently have or have had liver problems, or are allergic to EstroGel or any of its ingredients.

Before using EstroGel, tell your healthcare provider about all of your medical conditions, including if you have any unusual vaginal bleeding, have any other medical conditions that may become worse while you are using EstroGel, are going to have surgery or will be on bed rest, are pregnant or think you may be pregnant, are breastfeeding, and about all the medicines you take.

In general, the addition of a progestogen is recommended for women with a uterus to reduce the chance of getting cancer of the uterus (womb).  See your healthcare provider right away if you get vaginal bleeding while using EstroGel

Serious but less common side effects include heart attack, stroke, blood clots, breast cancer, cancer of the lining of the uterus (womb), cancer of the ovary, dementia, high or low blood calcium, gallbladder disease, visual abnormalities, high blood pressure, high levels of fat (triglycerides) in your blood, liver problems, changes in your thyroid hormone levels, fluid retention, cancer changes of endometriosis, enlargement of benign tumors of the uterus (“fibroids”), worsening of swelling of face and tongue (angioedema) in women with a history of angioedema, and changes in laboratory test results such as bleeding time and high blood sugar.

Call your healthcare provider right away if you get any of the following symptoms: new breast lumps; unusual vaginal bleeding; changes in vision or speech; sudden new severe headaches; severe pains in your chest or legs with or without shortness of breath, weakness and fatigue; swelling of face, lips, and tongue with or without red itchy bumps.

Common side effects of  EstroGel include headache, breast tenderness or pain, stomach or abdominal cramps, bloating, nausea and vomiting, hair loss, fluid retention, and vaginal yeast infection.

If you would like more information, talk with your healthcare provider.  You may report side effects to ASCEND Therapeutics^® US, LLC at 1‑877-204-1013

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please click the links below to download PDF versions of the following documents:

Full Prescribing Information including boxed warning
Patient Information

For more information, please visit EstroGel.com

Please click the links below to download PDF versions of the following documents:

Full Prescribing Information including boxed warning
Medication Guide

For more information and instructions for use, please visit www.androgel.com

USE AND IMPORTANT SAFETY INFORMATION

USE

AndroGel® (testosterone gel) 1% and 1.62% are controlled substances, available by prescription, used to treat adult males who have low or no testosterone due to certain medical conditions.

It is not known if AndroGel is safe or effective to treat men who have low testosterone due to aging.

It is not known if AndroGel is safe or effective in children younger than 18 years old.

AndroGel is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. Keep it in a safe place to protect it and never give it to anyone else. Selling or giving away this medicine may harm others and is against the law.

AndroGel is not meant for use in women.

IMPORTANT SAFETY INFORMATION

• AndroGel can transfer from your body to others, including children and women. This can happen if other people come into contact with the area where the AndroGel was applied. Children and women should avoid contact with the unwashed or not covered (unclothed) areas where AndroGel has been applied to your skin.
• Early signs and symptoms of puberty have occurred in young children who have come in direct contact with testosterone by touching areas where men have used AndroGel.
• Signs and symptoms of early puberty in a child who has come in direct contact with AndroGel may include:
  • Abnormal sexual changes:
    • Enlarged penis or clitoris.
    • Early growth of hair near the vagina or around the penis (pubic hair).
    • Erections or acting out sexual urges (sex drive).
  • Behavior problems, including acting aggressively or behaving in an angry or violent way.
• Signs and symptoms in a woman who has come in direct contact with AndroGel may include:
  • Changes in body hair.
  • An abnormal increase in pimples (acne).
• To lower the risk of transfer of AndroGel from your body to others, you should follow these important instructions:
  • Apply AndroGel 1.62% only to your shoulders and upper arms that will be covered by a short-sleeve t-shirt.
  • Apply AndroGel 1% only to areas of your shoulders, upper arms, or stomach area (abdomen) that will be covered by a short-sleeve t-shirt.
  • Wash your hands right away with soap and water after applying AndroGel.
  • After the gel has dried, cover the application area with clothing. Keep the area covered until you have washed the application area well or have showered.
  • If you expect to have skin-to-skin contact with another person, first wash the application area well with soap and water.
  • If a child or woman touches the area where you have applied AndroGel, that area on the child or woman should be washed well with soap and water right away.
• Stop using AndroGel and call your healthcare provider right away if you see any signs and symptoms of puberty in a child, or changes in body hair or increased acne in a woman, that may have happened through accidental touching of the area where you have applied AndroGel.
• Do not use AndroGel if you:
  • Have breast cancer or have or might have prostate cancer.
  • Are pregnant. AndroGel may harm your unborn baby. Women who are pregnant should avoid contact with the area of skin where AndroGel has been applied.
• Before using AndroGel, tell your healthcare provider about all of your medical conditions, including if you have breast cancer; prostate cancer; urinary problems due to enlarged prostate; heart, kidney, or liver problems; or problems breathing while you sleep (sleep apnea).
• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take insulin, medicines that decrease blood clotting (blood thinners), or corticosteroids.
• AndroGel can cause serious side effects, including:
  • If you already have an enlargement of your prostate gland, your signs and symptoms can get worse while using AndroGel (including changes in urination).
  • Possible increased risk of prostate cancer.
  • Blood clots in the legs or lungs. Signs and symptoms of a blood clot in your leg can include leg pain, swelling, or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain.
  • Possible increased risk of heart attack or stroke.
  • In large doses, AndroGel may lower your sperm count.
  • Swelling of your ankles, feet, or body, with or without heart failure. This may cause serious problems for people who have heart, kidney, or liver disease.
  • Enlarged or painful breasts.
  • Having problems breathing while you sleep (sleep apnea).
• The most common side effects of AndroGel 1.62% include increased prostate specific antigen (a test used to screen for prostate cancer), mood swings, high blood pressure, increased red blood cell count, and skin irritation where the gel is applied.
• The most common side effects of AndroGel 1% include acne, skin irritation where AndroGel 1% is applied, lab test changes, and increased prostate specific antigen.
• This is the most important information to know about AndroGel. For further information, talk with your healthcare You may report side effects to ASCEND Therapeutics^®US, LLC at 1-877-204-1013.

Please see the full Prescribing Information, including BOXED WARNING, and Medication Guide for AndroGel 1% and please see the full Prescribing Information, including BOXED WARNING, and Medication Guide for AndroGel 1.62%.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

BINOSTO Important Safety Information

BINOSTO® (alendronate sodium) effervescent tablets for oral solution 70mg is a prescription medicine used to:

• Treat thinning of your bones (osteoporosis) in women after menopause.  BINOSTO helps reduce the chance of having a hip or spinal fracture (break).
• Increase bone mass in men who have osteoporosis

It is not known how long BINOSTO works for the treatment of osteoporosis. You should see your doctor regularly to determine if BINOSTO is still right for you.

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT BINOSTO EFFERVESCENT TABLET?

BINOSTO Effervescent Tablet can cause serious side effects, including:

1. Esophagus Problems: Some people who take BINOSTO may develop problems in the esophagus (the tube that connects the mouth and the stomach). These problems include irritation, inflammation, or ulcers of the esophagus which may sometimes bleed
   • It is important to take BINOSTO exactly as prescribed to help lower the chance of getting esophagus problems. BINOSTO should be taken after getting up for the day and 30 minutes before taking the first food, drink, or other medicine.
   • Stop taking BINOSTO and call your doctor right away if you get chest pain, new or worsening heartburn, or have trouble or pain when swallowing.
2. Low calcium levels in the blood (hypocalcemia): BINOSTO may lower the calcium levels in your blood. If you have low blood calcium before you start taking BINOSTO, it may get worse during treatment. Your Low blood calcium must be treated before taking BINOSTO. Most people with low blood calcium levels do not have symptoms, but some people may have symptoms. Call your doctor right away if you have symptoms of low blood calcium such as: Spasms, twitches, or cramps in your muscles or Numbness or tingling in your fingers, toes, or around your mouth.
3. Bone, joint, or muscle pain: Some people who take BINOSTO develop severe bone, joint, or muscle pain.
4. Severe jaw bone problems (osteonecrosis): Severe jaw bone problems may happen when you take BINOSTO. Your doctor should examine your mouth before starting BINOSTO. Your doctor may tell you to see your dentist before starting BINOSTO. It is important to practice good mouth care during treatment with BINOSTO
5. Unusual thigh bone fractures: Some people have developed unusual fractures in their thigh bone. Symptoms of a fracture may include new or unusual pain in the hip, groin, or thigh
   Call your doctor right away if you have any of these side effects.

 Do not take BINOSTO if you:

• Have certain problems with their esophagus, the tube that connects your mouth with your stomach
• Cannot stand or sit upright for at least 30 minutes
• Have trouble swallowing liquids
• Have low levels of calcium in their blood
• Become pregnant or suspect that you are pregnant or planning to become pregnant
• Are allergic to BINOSTO or any of its ingredients

Tell your doctor about all of your medical conditions, including if you have problems with swallowing, stomach or digestive problems, low blood calcium, plan to have dental surgery or teeth removed, kidney problems, trouble absorbing minerals in your stomach or intestines (malabsorption syndrome), been told to lower your salt intake, are pregnant, planning to become pregnant or suspect that you are pregnant, or are breastfeeding or plan to breastfeed.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements, especially if you take calcium, antacids, aspirin, nonsteroidal anti-inflammatory (NSAID) medicines.

BINOSTO contains a high amount of salt in each tablet. Avoid eating foods with a high amount of salt if your doctor has told you to limit how much salt you eat.

Common side effects of BINOSTO are stomach area (abdominal) pain, heartburn, constipation, diarrhea, wind, upset stomach, pain in bones, joints or muscles and nausea. You may get allergic reactions, such as hives, swelling of your face, lips, tongue, or throat.

If you would like more information, talk with your healthcare provider. You may report side effects to ASCEND Therapeutics^® US, LLC at 1-877-204-1013

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see Medication Guide for more details at www.binosto.com.