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Dg Health Nicotine
nicotine polacrilex · Dg Health Nicotine is a cholinergic nicotinic agonist (over-the-counter) containing nicotine polacrilex, made by Dolgencorp Inc.
- 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
- Gum, chewing, Lozenge
- Label holder
- Dolgencorp Inc
- FDA application
- ANDA203690
- Label updated
- 07/01/2026
Active ingredients
(in each lozenge) Nicotine polacrilex, 4 mg (nicotine)
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. 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.
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 a 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).
Ask a doctor before use
- 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 a 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)
Pregnancy or breastfeeding
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.
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).
Other information
- Store at 20-25°C (68-77°F)
- Keep vial tightly closed and protect from light
Inactive ingredients
Acesulfame potassium, calcium polycarbophil, magnesium stearate, mannitol, natural and artificial mint flavor, potassium bicarbonate, sodium alginate, sodium carbonate, sucralose, xanthan gum
Questions?
Call toll-free 1-866-751-9303
Forms and strengths
From the FDA NDC Directory · 2 product codes
| Dosage form | Strength | Route | NDCs |
|---|---|---|---|
| Gum, chewing | 4 mg | oral | 1 |
| Lozenge | 4 mg | oral | 1 |
Manufacturers and labels
2 FDA labels
- Dolgencorp IncShown hereANDA203690 · Label 07/01/2026 · NDC 55910-669Full label
- Dolgencorp IncANDA076779 · Label 06/11/2026 · NDC 55910-122Full label
Related recalls
FDA drug recalls that name this drug or its active ingredient
- Class IIIDrugOngoing06/03/2026Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by: RUGBY LABORATORIES...AVEVA Drug Delivery Systems, Inc. · Failed Impurities/Degradation Specifications: Elevated levels of...
- Class IIIDrug10/07/2020Nicotine Gum, Nicotine Polacrilex Gum USP, 2 mg (nicotine), 110-count pieces per carton, Distributed By...P & L Developments, LLC · Labeling: Incorrect or Missing Package Insert: The package insert...
- Class IIIDrug09/03/2014Nicotine Polacrilex Lozenge, 2 mg Mint Mini. 27 Ct Tubes, Over the Counter. Perrigo, 502 Eastern Ave...Perrigo Holland Inc · Failed Dissolution Specifications and Failed Tablet...
- Class IIIDrug04/30/2014Nicotine polacrilex lozenge, 2 mg, Cherry Flavor, 72 count vials, 81 count vials, and 108 count vials....GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline · 10 products · Failed Lozenge Specifications; Lozenges are overly thick, overly...
- Class IIDrug01/29/2014NICOTINE POLACRILEX, LOZENGE, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00135051001.Aidapak Services, LLC · 2 products · Labeling: Label Mixup: NICOTINE POLACRILEX, LOZENGE, 2 mg may have...
Dg Health Nicotine: common questions
- What is Dg Health Nicotine used for?
- • reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
- Is Dg Health Nicotine a prescription drug?
- No. Dg Health Nicotine is sold over the counter (OTC) without a prescription.
- Are there other products with the same active ingredient as Dg Health Nicotine?
- Yes. Other FDA-listed products with the same active ingredients include Nicotine, Nicotine Mini, Nicotine Polacrilex, Mini Nicotine.
- Who makes Dg Health Nicotine?
- Dolgencorp Inc lists Dg Health Nicotine with the FDA.
Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 07/01/2026 · Label text is shown as published by the manufacturer. Not medical advice