Label: LEVONORGESTREL tablet
- NDC Code(s): 76519-1164-0
- Packager: H.J. Harkins Company, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated September 18, 2019
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
Allergy alert: Do not use if you have ever had an allergic reaction to levonorgestrel.
Sexually transmitted diseases (STDs) alert: This product does not protect against HIV/AIDS or other STDs
Do not use
if you are already pregnant (because it will not work)
for regular birth control
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 levonorgestrel.
When using this product you may have
lower stomach (abdominal) pain
- KEEP OUT OF REACH OF CHILDREN
DOSAGE & ADMINISTRATION
take as soon as possible within 72 hours (3 days) after unprotected sex. The sooner you take it the better it will work.
if you vomit within 2 hours after taking the medication, call a healthcare professional to find out if you should repeat the dose.
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 25°C (77°C); excursions permitted to 15 to 30°C (59 to 86°C) [see USP Controlled Room temperature].
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76519-1164 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 LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POVIDONE K30 (UNII: U725QWY32X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color white Score no score Shape ROUND Size 9mm Flavor Imprint Code LU;S25 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76519-1164-0 1 in 1 BOX; Type 0: Not a Combination Product 11/15/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA201446 11/15/2017 Labeler - H.J. Harkins Company, Inc. (147681894) Establishment Name Address ID/FEI Business Operations H.J. Harkins Company, Inc. 147681894 manufacture(76519-1164) , relabel(76519-1164) , repack(76519-1164)