RESTART- levonorgestrel tablet

Restart by

Drug Labeling and Warnings

Restart by is a Otc medication manufactured, distributed, or labeled by Winx Health Inc., Naari Pharma Private Limited . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

• 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

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

• Menstrual changes
• Tiredness
• Breast pain
• Nausea
• Headache
• Vomiting
• Lower stomach (abdominal) pain
• Dizziness

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Colloidal Silicon Dioxide, Corn Starch, Lactose Monohydrate, Magnesium Dtearate, Povidone

For women to reduce chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use birth control)

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Emergency Contraceptive

Levonorgestrel 1.5 mg

INGREDIENTS AND APPEARANCE

RESTART 
levonorgestrel tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80584-103
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)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
TALC (UNII: 7SEV7J4R1U)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	orange (Light peach)	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	17
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80584-103-01	1 in 1 CARTON	10/08/2024
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	ANDA207660	10/08/2024

Labeler - Winx Health Inc. (117116737)

Establishment
Name	Address	ID/FEI	Business Operations
Naari Pharma Private Limited		915787058	manufacture(80584-103) , analysis(80584-103) , label(80584-103) , pack(80584-103)