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NDC 17856-1241-01 Mini Nicotine 4 mg/1 Details

Mini Nicotine 4 mg/1

Mini Nicotine is a ORAL LOZENGE in the HUMAN OTC DRUG category. It is labeled and distributed by ATLANTIC BIOLOGICALS CORP.. The primary component is NICOTINE.

MedlinePlus Drug Summary

Nicotine lozenges are used to help people stop smoking. Nicotine lozenges are in a class of medications called smoking cessation aids. They work by providing nicotine to your body to decrease the withdrawal symptoms experienced when smoking is stopped and to reduce the urge to smoke.

Related Packages: 17856-1241-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Nicotine Lozenges

Product Information

NDC	17856-1241
Product ID	17856-1241_35c75733-3e2b-4be6-8e78-bf6b354db3c1
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Mini Nicotine
Proprietary Name Suffix	n/a
Non-Proprietary Name	Nicotine Polacrilex
Product Type	HUMAN OTC DRUG
Dosage Form	LOZENGE
Route	ORAL
Active Ingredient Strength	4
Active Ingredient Units	mg/1
Substance Name	NICOTINE
Labeler Name	ATLANTIC BIOLOGICALS CORP.
Pharmaceutical Class	Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA207868
Listing Certified Through	2023-12-31

Package

Package Images

NDC 17856-1241-01 (17856124101)

Pricing Information	N/A
NDC Package Code	17856-1241-1
Billing NDC	17856124101
Package	50 POUCH in 1 BOX (17856-1241-1) / 1 LOZENGE in 1 POUCH (17856-1241-2)
Marketing Start Date	2022-09-08
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a0fc3eae-9c34-48af-bdd2-d95e91b68a9c Details

Active ingredient (in each lozenge)

Nicotine polacrilex 4 mg

Purpose

Stop smoking aid

Use

reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking

Warnings

If you are pregnant or breast-feeding,

only use this medicine on the advice of your health care provider. Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine. This medicine is believed to be safer than smoking. However, the risks to your child from this medicine are not fully known.

Ask a doctor before use if you have

heart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate.
high blood pressure not controlled with medication. Nicotine can increase your blood pressure.
stomach ulcer or diabetes
history of seizures

Ask a doctor or pharmacist before use if you are

using a non-nicotine stop smoking drug
taking prescription medicine for depression or asthma. Your prescription dose may need to be adjusted.

Stop use and ask a doctor if

mouth problems occur
persistent indigestion or severe sore throat occurs
irregular heartbeat or palpitations occur
you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, weakness and rapid heartbeat
you have symptoms of an allergic reaction (such as difficulty breathing or rash)

Keep out of reach of children and pets.

Nicotine lozenges may have enough nicotine to make children and pets sick. If you need to remove the lozenge, wrap it in paper and throw away in the trash. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)

Directions (4 mg lozenge)

if you are under 18 years of age, ask a doctor before use. No studies have been done to show if this product will work for you.
before using this product, read the enclosed User’s Guide for complete directions and other important information
begin using the lozenge on your quit day
if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine lozenge
if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine lozenge according to the following 12 week schedule:

Weeks 1 to 6	Weeks 7 to 9	Weeks 10 to 12
1 lozenge every 1 to 2 hours	1 lozenge every 2 to 4 hours	1 lozenge every 4 to 8 hours

nicotine lozenge is a medicine and must be used a certain way to get the best results
place the lozenge in your mouth and allow the lozenge to slowly dissolve. Minimize swallowing. Do not chew or swallow lozenge.
you may feel a warm or tingling sensation
occasionally move the lozenge from one side of your mouth to the other until completely dissolved
do not eat or drink 15 minutes before using or while the lozenge is in your mouth
to improve your chances of quitting, use at least 9 lozenges per day for the first 6 weeks
do not use more than one lozenge at a time or continuously use one lozenge after another since this may cause you hiccups, heartburn, nausea or other side effects
do not use more than 5 lozenges in 6 hours. Do not use more than 20 lozenges per day.
It is important to complete treatment. If you feel you need to use the lozenge for a longer period to keep from smoking, talk to your health care provider.

Other information

Phenylketonurics: Contains Phenylalanine 2.8 mg per lozenge
store at 20-25ºC (68-77ºF)
keep vial tightly closed and protect from light

Inactive ingredients

aspartame, calcium polycarbophil, flavor, maltodextrin, mannitol, sodium alginate, sodium bicarbonate, sodium stearyl fumarate, talc, xanthan gum

Questions or comments?

Call 1-800-645-2158

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL 33179

Package Label (4 mg lozenge)

INGREDIENTS AND APPEARANCE

MINI NICOTINE

nicotine polacrilex lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:17856-1241(NDC:0536-1241)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R)	NICOTINE	4 mg

Ingredient Name	Strength
Inactive Ingredients
ASPARTAME (UNII: Z0H242BBR1)
CALCIUM POLYCARBOPHIL (UNII: 8F049NKY49)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MANNITOL (UNII: 3OWL53L36A)
SODIUM ALGINATE (UNII: C269C4G2ZQ)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
TALC (UNII: 7SEV7J4R1U)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL	Size	10mm
Flavor	MINT	Imprint Code	131
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:17856-1241-1	50 in 1 BOX	09/08/2022
1	NDC:17856-1241-2	1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA207868	07/31/2019

Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)

Registrant - ATLANTIC BIOLOGICALS CORP. (047437707)

Name	Address	ID/FEI	Business Operations
Establishment
UNIT DOSE SOLUTIONS		360804194	repack(17856-1241)

Revised: 9/2022

Document Id: 35c75733-3e2b-4be6-8e78-bf6b354db3c1

Set id: a0fc3eae-9c34-48af-bdd2-d95e91b68a9c

Version: 1

Effective Time: 20220908