Label: NEW DAY- levonorgestrel tablet
- NDC Code(s): 16714-809-01
- Packager: Northstar Rx LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated October 25, 2023
If you are a consumer or patient please visit this version.
- Drug Facts
- Active Ingredient
- Do not use
- Ask a doctor or pharmacist before use if you are
- When using this product you may have
- Keep out of reach of children.
- Other information
- Inactive ingredients
- Questions or comments?
- New Day
- What is New Day®?
- What New Day® is not.
When should I use New Day®?
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®.
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.
- How does New Day® work?
- How can I get the best results from New Day®?
- How effective is New Day®?
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.
Will I experience any side effects?
•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®?
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.
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) 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, PREGELATINIZED CORN (UNII: O8232NY3SJ) POLYVINYL ALCOHOL (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:16714-809-01 1 in 1 CARTON 03/11/2016 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 - Northstar Rx LLC (830546433) Registrant - Novast Laboratories, Ltd. (527695995) Establishment Name Address ID/FEI Business Operations Novast Laboratories, Ltd. 527695995 analysis(16714-809) , label(16714-809) , manufacture(16714-809) , pack(16714-809)