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NDC 70000-0561-01 Maxi Nicotine 4 mg/1 Details
Maxi Nicotine 4 mg/1
Maxi Nicotine is a ORAL LOZENGE in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health (Leader) 70000. 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: 70000-0561-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Nicotine Lozenges
Product Information
| NDC | 70000-0561 |
|---|---|
| Product ID | 70000-0561_68f0502e-c46e-4e7b-b3f8-ed8f12326542 |
| Associated GPIs | 62100010004720 |
| GCN Sequence Number | 048775 |
| GCN Sequence Number Description | nicotine polacrilex LOZENGE 4 MG BUCCAL |
| HIC3 | J3A |
| HIC3 Description | SMOKING DETERRENT AGENTS (GANGLIONIC STIM,OTHERS) |
| GCN | 14688 |
| HICL Sequence Number | 002049 |
| HICL Sequence Number Description | NICOTINE POLACRILEX |
| Brand/Generic | Generic |
| Proprietary Name | Maxi 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 | Cardinal Health (Leader) 70000 |
| Pharmaceutical Class | Cholinergic Nicotinic Agonist [EPC], Nicotine [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA209206 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 70000-0561-01 (70000056101)
| NDC Package Code | 70000-0561-1 |
|---|---|
| Billing NDC | 70000056101 |
| Package | 3 BOTTLE, PLASTIC in 1 BOX (70000-0561-1) / 24 LOZENGE in 1 BOTTLE, PLASTIC |
| Marketing Start Date | 2020-07-01 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.33133 |
| Pricing Unit | EA |
| Effective Date | 2024-02-21 |
| NDC Description | NICOTINE 4 MG LOZENGE |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 1 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |
Standard Product Labeling (SPL)/Prescribing Information SPL 362b4a04-4a5f-4af6-9cd7-82aa172b7afb Details
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 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)
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.
Other information
Inactive ingredients
Principal Display Panel
COMPARE TO NICORETTE® LOZENGE active ingredient*
Nicotine Lozenges
Nicotine Polacrilex 4 mg
Stop Smoking Aid
Mint Flavor
FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE WITHIN 30 MINUTES OF WAKING UP.
If you smoke your first cigarette MORE THAN 30 MINUTES after waking up, use Nicotine Polacrilex 2 mg Lozenge.
LOZENGES
TO INCREASE YOUR SUCCESS IN QUITTING:
1. You must be motivated to quit.
2. Use Enough - Use at least 9 Nicotine Polacrilex lozenges per day during the first six weeks.
3. Use Long Enough - Use Nicotine Polacrilex lozenges for the full 12 weeks.
4. Use With a Support Program as directed in the enclosed User's Guide.
- not for sale to those under 18 years of age
- proof of age required
- not for sale in vending machines or from any source where proof of age cannot be verified
*This product is not manufactured or distributed by GlaxoSmithKline Consumer Healthcare, L.P., distributor of Nicorette® Lozenge.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR FULL PRODUCT USES, DIRECTIONS AND WARNINGS.
DISTRIBUTED BY:
CARDINAL HEALTH
DUBLIN, OHIO 43017
INGREDIENTS AND APPEARANCE
| MAXI NICOTINE
nicotine polacrilex lozenge |
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| Labeler - Cardinal Health (Leader) 70000 (063997360) |