Label: NEW DAY- levonorgestrel tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 76413-357-01 - Packager: Central Texas Community Health Centers
- This is a repackaged label.
- Source NDC Code(s): 16714-809
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 9, 2019
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
- 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 blister seal is broken or missing.
•Store at 20° to 25°C (68° to 77°F).
- INACTIVE INGREDIENT
- QUESTIONS
- New Day™
- What is New Day™? What You Need to Know
- What New Day™ is not.
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When should I use New Day™?
The sooner you take emergency contraception, the better it works. You should use New Day™ within 72 hour s (3 days) after you have had unprotected sex.
New Day™ 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 New Day™.
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When should I talk to a doctor or pharmacist?
Ask a doctor or pharmacist before use if you are taking efavirenz (HIV medication) or rifampin (tuberculosis treatment) or medication for seizures (epilepsy). These medications may reduce the effectiveness of New Day™ and increase your chance of becoming pregnant. Your doctor may prescribe another form of emergency contraception that may not be affected by these medications.
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How does New Day™ work?
New Day™ is one tablet with levonorgestrel, a hormone that has been used in many birth control pills for several decades. New Day™ 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 New Day™ 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 New Day™?
- How effective is New Day™?
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How will I know New Day™ worked?
You will know New Day™ 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, New Day™ 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 New Day™?
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Other Information
Keep out of reach of children:
In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.
Do not use if the blister seal is opened.
Store at room temperature 20° to 25°C (68° to 77°F).
Active ingredient: levonorgestrel 1.5 mg
Inactive ingredients: magnesium stearate, lactose monohydrate, pregelatinized starch, polyvinyl alcohol, titanium dioxide, talc, macrogol/PEG, lecithin (soya), FD&C red#40 aluminum lake, FD&C yellow#6 aluminum lake, FD&C blue#1 aluminum lake.
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.
- HOW SUPPLIED
- NEW DAY (LEVONORGESTREL) TABLET
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INGREDIENTS AND APPEARANCE
NEW DAY
levonorgestrel tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76413-357(NDC:16714-809) 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 MAGNESIUM STEARATE (UNII: 70097M6I30) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) STARCH, CORN (UNII: O8232NY3SJ) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TALC (UNII: 7SEV7J4R1U) POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Product Characteristics Color PINK Score no score Shape ROUND Size 8mm Flavor Imprint Code 15 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76413-357-01 1 in 1 CARTON 01/09/2019 1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207976 03/11/2016 Labeler - Central Texas Community Health Centers (079674019) Establishment Name Address ID/FEI Business Operations Central Texas Community Health Centers 079674019 RELABEL(76413-357) , REPACK(76413-357)