Nicotine Polacrilex 4 mg/1
Nicotine Polacrilex · LOZENGE · Bryant Ranch Prepack
Nicotine Polacrilex is a lozenge containing nicotine polacrilex at 4 mg/1, taken oral. Manufactured by Bryant Ranch Prepack.
Key Facts
- Brand Name
- Nicotine Polacrilex
- Generic Name
- Nicotine Polacrilex
- NDC Code (Product)
72162-2288- Manufacturer
- Bryant Ranch Prepack
- Strength
- 4 mg/1
- Dosage Form
- LOZENGE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA203690
- Drug Class
- Cholinergic Nicotinic Agonist [EPC]
- Marketing Start
- 07/08/2016
Recall History
Aidapak Services, LLC
Labeling: Label Mixup: NICOTINE POLACRILEX, LOZENGE, 2 mg may have potentially been mislabeled as one of the following drugs: ESTRADIOL, Tablet, 0.5 mg, NDC 00555089902, Pedigree: AD30993_11, EXP: 5/9/2014; ACAMPROSATE CALCIUM DR, Tablet, 333 mg, NDC 00456333001, Pedigree: W002973, EXP: 6/11/2014; CALCITRIOL, Capsule, 0.5 mcg, NDC 63304024001, Pedigree: W003730, EXP: 6/26/2014; ESZOPICLONE, T
GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Aidapak Services, LLC
Labeling: Label Mixup:NICOTINE POLACRILEX, GUM, 2 mg may have potentially been mislabeled as one of the following drugs: FOLIC ACID, Tablet, 1 mg, NDC 65162036110, Pedigree: AD33897_22, EXP: 5/9/2014; QUEtiapine FUMARATE, Tablet, 25 mg, NDC 60505313001, Pedigree: W003099, EXP: 6/13/2014.
Perrigo Holland Inc
Failed Dissolution Specifications and Failed Tablet Specifications: High 30 minute dissolution test and presence of broken lozenges.
GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Aidapak Services, LLC
Labeling: Label Mixup; NICOTINE POLACRILEX Gum, 2 mg may be potentially mislabeled as SACCHAROMYCES BOULARDII LYO, Capsule, 250 mg, NDC 00414200007, Pedigree: AD54586_4, EXP: 5/21/2014.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Use reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
Dosage & Administration
Directions 2 mg : 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 within 30 minutes of waking up, use 4 mg nicotine lozenge if you smoke your first cigarette more than 30 minutes after waking up, use 2 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 20-30 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 20-30 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 lozen…
Warnings
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 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 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 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 ch…
Frequently Asked Questions
What is Nicotine Polacrilex used for?
Nicotine Polacrilex contains Nicotine Polacrilex. It is a lozenge taken oral. Consult your doctor for specific uses.
Is Nicotine Polacrilex a controlled substance?
Nicotine Polacrilex is not classified as a controlled substance by the DEA.
What is the generic name for Nicotine Polacrilex?
The generic name for Nicotine Polacrilex is Nicotine Polacrilex. There are 11 other brand versions of Nicotine Polacrilex.
What is the NDC code for Nicotine Polacrilex 4 mg/1?
The NDC (National Drug Code) for Nicotine Polacrilex 4 mg/1 is 72162-2288, listed by Bryant Ranch Prepack.
Other Nicotine Brands
See all →- Nicotine4 mg/172224-930
- Basic Care Nicotine4 mg/172288-003
- basic care nicotine2 mg/172288-206
- basic care nicotine4 mg/172288-532
- AMAZON BASIC CARE NICOTINE POLACRILEX4 mg/172288-690
- Habitrol Nicotine Polacrilex Gum 4 mg Coated Mint4 mg/175907-303
- topcare nicotine4 mg/176162-700
- nicotine4 mg/179481-1100
- BLIP4 mg/182966-303
- nicotine2 mg/111822-0201
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)