Label: LEVONORGESTREL tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 68071-4126-1 - Packager: NuCare Pharmaceuticals,Inc.
- This is a repackaged label.
- Source NDC Code(s): 51285-100
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application Authorized Generic
Drug Label Information
Updated February 12, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Purpose
- Use
- Warnings
- Do not use
- When using this product you may have
- Keep out of reach of children.
- Directions
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Other information
- read the instructions, warnings and enclosed product leaflet before use
- this product works mainly by preventing ovulation (egg release). It may also prevent fertilization of a released egg (joining of sperm and egg) or attachment of a fertilized egg to the uterus (implantation).
- do not use if carton is open or tear strip is removed or blister seal is broken or missing.
- store at 20-25°C (68-77°F)
- Inactive ingredients
- Questions?
- CONSUMER INFORMATION
- What is Take Action ®?
- What Take Action ® is not.
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When should I use Take Action
®?
The sooner you take emergency contraception, the better it works. You should use Take Action ® within 72 hours (3 days) after you have had unprotected sex.
Take Action ® is a backup or emergency method of birth control you can use when:
- your regular birth control was used incorrectly or failed
- you did not use any birth control method
- When not to use Take Action ®?
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How does Take Action
® work?
Take Action ® is one tablet with levonorgestrel, a hormone that has been used in many birth control pills for several decades. Take Action ® contains a higher dose of levonorgestrel than birth control pills, but works in a similar way to prevent pregnancy. It works mainly by stopping the release of an egg from the ovary. It is possible that Take Action ® may also work by preventing fertilization of an egg (the uniting of sperm with the egg) or by preventing attachment (implantation) to the uterus (womb).
- How can I get the best results from Take Action ®?
- How effective is Take Action ®?
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How will I know if Take Action
® worked?
You will know Take Action ® has been effective when you get your next period, which should come at the expected time, or within a week of the expected time. If your period is delayed beyond 1 week, it is possible you may be pregnant. You should get a pregnancy test and follow up with your healthcare professional.
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Will I experience any side effects?
- some women may have changes in their period, such as a period that is heavier or lighter or a period that is early or late. If your period is more than a week late, you may be pregnant.
- if you have severe abdominal pain, you may have an ectopic pregnancy, and should get immediate medical attention.
- when used as directed, Take Action ® is safe and effective. Side effects may include changes in your period, nausea, lower stomach (abdominal) pain, tiredness, headache, dizziness, and breast tenderness.
- If you vomit within 2 hours of taking the medication, call a healthcare professional to find out if you should repeat the dose.
- What if I still have questions about Take Action ®?
- Other information
- Keep out of reach of children:
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Do not use if the blister seal is opened.
Store at room temperature 20-25°C (68-77°F).
You may report side effects to FDA at 1-800-FDA-1088.Active ingredient: levonorgestrel 1.5 mg
Inactive ingredients: colloidal silicon dioxide, potato starch, magnesium stearate, talc, corn starch, lactose monohydrate
1-866-626-6990
If you are sexually active, you should see a healthcare provider for routine checkups. Your healthcare provider will talk to you about, and if necessary, test you for sexually transmitted diseases, teach you about effective methods of routine birth control, and answer any other questions you may have.
©2013 Teva Women’s Health, Inc.
Rev. 11/2014 - Principal Display Panel
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INGREDIENTS AND APPEARANCE
LEVONORGESTREL
levonorgestrel tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68071-4126(NDC:51285-100) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW) LEVONORGESTREL 1.5 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) STARCH, POTATO (UNII: 8I089SAH3T) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color white Score no score Shape ROUND Size 8mm Flavor Imprint Code G00 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68071-4126-1 1 in 1 BOX; Type 0: Not a Combination Product 10/25/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA authorized generic NDA021998 02/17/2014 Labeler - NuCare Pharmaceuticals,Inc. (010632300) Establishment Name Address ID/FEI Business Operations NuCare Pharmaceuticals,Inc. 010632300 relabel(68071-4126)