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Amazon Basic Care Nicotine Polacrilex

nicotine polacrilex · Amazon Basic Care Nicotine Polacrilex is a cholinergic nicotinic agonist (over-the-counter) containing nicotine polacrilex, made by Amazon.com Services LLC.

Type
Over the counter
Drug class
Cholinergic Nicotinic Agonist
Route
Oral
Manufacturers
1

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

Drug facts

Generic name
nicotine polacrilex
Active ingredients
Nicotine
Drug class
Cholinergic Nicotinic Agonist
Dosage forms
Lozenge
Label holder
Amazon.com Services LLC
FDA application
ANDA213266
Label updated
05/02/2025

Active ingredients

Drug Facts Active ingredient (in each lozenge) Nicotine polacrilex USP, 4 mg

Purpose

Stop smoking aid

Uses

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

Directions

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 (about 20 to 30 minutes). 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 (about 20 to 30 minutes) 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.

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.

Do not use

  • If you are allergic to soya

Ask a doctor before use

A sodium-restricted diet 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

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

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 (1-800-222-1222) right away.

Inactive ingredients

Artificial flavors, aspartame, calcium polycarbophil, colloidal silicon dioxide, corn syrup solids, dextrin, magnesium stearate, mannitol, modified food starch (corn), natural flavors, potassium bicarbonate, sodium alginate, sodium carbonate, xanthan gum Questions or comments? call 1-855-274-4122 (Monday - Friday 8:30 AM to 5:00 PM EST) DISTRIBUTED BY: AMAZON.COM SERVICES LLC 410 TERRY AVENUE N. SEATTLE, WA 98109 Made in India Issued: 02/2024

Forms and strengths

From the FDA NDC Directory · 2 product codes

Dosage formStrengthRouteNDCs
Lozenge2 mgoral1
Lozenge4 mgoral1

Manufacturers and labels

2 FDA labels

  • Amazon.com Services LLCShown hereANDA213266 · Label 05/02/2025 · NDC 72288-266Full label
  • Amazon.com Services LLCANDA213266 · Label 05/02/2025 · NDC 72288-623Full label

Related recalls

FDA drug recalls that name this drug or its active ingredient

All drug recalls

Amazon Basic Care Nicotine Polacrilex: common questions

What is Amazon Basic Care Nicotine Polacrilex used for?
reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
Is Amazon Basic Care Nicotine Polacrilex a prescription drug?
No. Amazon Basic Care Nicotine Polacrilex is sold over the counter (OTC) without a prescription.
Are there other products with the same active ingredient as Amazon Basic Care Nicotine Polacrilex?
Yes. Other FDA-listed products with the same active ingredients include Nicotine, Nicotine Mini, Nicotine Polacrilex, Mini Nicotine.
Who makes Amazon Basic Care Nicotine Polacrilex?
Amazon.com Services LLC lists Amazon Basic Care Nicotine Polacrilex with the FDA.

Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 05/02/2025 · Label text is shown as published by the manufacturer. Not medical advice