MORNING AFTER PILL- levonorgestrel tablet

Morning After Pill by

Drug Labeling and Warnings

Morning After Pill by is a Otc medication manufactured, distributed, or labeled by Cadence Health Inc, Naari Pte. Limited, Haupt Pharma Muenster GmbH. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Levonorgestrel 1.5 mg

Purpose

Emergency contraceptive

Use

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

Warnings

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 DOCTOR

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

When using this product you may have

• menstrual changes
• nausea
• lower stomach (abdominal) pain
• tiredness
• headache
• dizziness
• breast pain
• vomiting

KEEP OUT OF REACH OF CHILDREN

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

Directions

• 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 of taking the medication, call a healthcare professional to find out if you should repeat the dose

Other information

• read the instructions, warnings, and enclosed product leaflet before use
• 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 ingredients

colloidal silicon dioxide, FD&C Yellow No.6 aluminum lake, lactose monohydrate, magnesium stearate, and pregelatinized starch

Questions or comments?

Call 1-877-862-7455
Monday - Friday 8 AM - 5 PM CST or visit us at cadenceotc.com

SPL UNCLASSIFIED SECTION

Manufactured for:
Cadence OTC

Oakland CA, 94612

NDC: 73436-2859-1

Product made in Germany
Issued: September 2023

PRINCIPAL DISPLAY PANEL

1. NDC: 73436-2859-1

Morning After Pill TM

Levonorgestrel 1.5 mg

Emergency contraceptive

Reduces chance of pregnancy after unprotected sex

Not for regular birth control

Won't interefere with your ability to get pregnant later

• The sooner you take it, the more effective it will be
• Take as soon as possible within 72 hours (3 days) after unprotected sex
• Will not harm an existing pregnancy

1 TABLET LEVONORGESTREL 1.5MG

INGREDIENTS AND APPEARANCE

MORNING AFTER PILL 
levonorgestrel tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73436-2859
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)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
STARCH, CORN (UNII: O8232NY3SJ)
MAGNESIUM STEARATE (UNII: 70097M6I30)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73436-2859-1	1 in 1 CARTON	10/01/2023
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	ANDA202380	10/01/2023

Labeler - Cadence Health Inc (116830263)

Registrant - Naari Pte. Limited (659345996)

Establishment
Name	Address	ID/FEI	Business Operations
Haupt Pharma Muenster GmbH		344172564	analysis(73436-2859) , manufacture(73436-2859) , pack(73436-2859)