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NDC 63739-0371-63 Nicotine 2 mg/1 Details
Nicotine 2 mg/1
Nicotine is a ORAL GUM, CHEWING in the HUMAN OTC DRUG category. It is labeled and distributed by McKesson Corporation dba SKY Packaging. The primary component is NICOTINE.
MedlinePlus Drug Summary
Nicotine chewing gum is used to help people stop smoking cigarettes. Nicotine chewing gum should be used together with a smoking cessation program, which may include support groups, counseling, or specific behavioral change techniques. Nicotine gum is in a class of medications called smoking cessation aids. It works by providing nicotine to your body to decrease the withdrawal symptoms experienced when smoking is stopped and as a substitute oral activity to reduce the urge to smoke.
Related Packages: 63739-0371-63Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Nicotine Gum
Product Information
| NDC | 63739-0371 |
|---|---|
| Product ID | 63739-371_7320d8e4-6736-4993-88f3-b7ca61ca981a |
| Associated GPIs | 62100010002810 |
| GCN Sequence Number | 004930 |
| GCN Sequence Number Description | nicotine polacrilex GUM 2 MG BUCCAL |
| HIC3 | J3A |
| HIC3 Description | SMOKING DETERRENT AGENTS (GANGLIONIC STIM,OTHERS) |
| GCN | 03200 |
| HICL Sequence Number | 002049 |
| HICL Sequence Number Description | NICOTINE POLACRILEX |
| Brand/Generic | Generic |
| Proprietary Name | Nicotine |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | nicotine polacrilex |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | GUM, CHEWING |
| Route | ORAL |
| Active Ingredient Strength | 2 |
| Active Ingredient Units | mg/1 |
| Substance Name | NICOTINE |
| Labeler Name | McKesson Corporation dba SKY Packaging |
| Pharmaceutical Class | Cholinergic Nicotinic Agonist [EPC], Nicotine [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA074507 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 63739-0371-63 (63739037163)
| NDC Package Code | 63739-371-63 |
|---|---|
| Billing NDC | 63739037163 |
| Package | 110 BLISTER PACK in 1 CARTON (63739-371-63) / 1 GUM, CHEWING in 1 BLISTER PACK |
| Marketing Start Date | 2020-04-27 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.24219 |
| Pricing Unit | EA |
| Effective Date | 2024-02-21 |
| NDC Description | NICOTINE 2 MG CHEWING GUM |
| 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 9ac37719-24c2-4ec7-9fb3-6408d8a5fc7a 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, teeth, or jaw problems occur
- 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.
Pieces of nicotine gum 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.
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 gum on your quit day
- if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine gum
- if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine gum according to the following 12 week schedule
| Weeks 1 to 6 | Weeks 7 to 9 | Weeks 10 to 12 |
| 1 piece every 1 to 2 hours | 1 piece every 2 to 4 hours | 1 piece every 4 to 8 hours |
- nicotine gum is a medicine and must be used a certain way to get the best results
- chew the gum slowly until it tingles. Then park it between your cheek and gum. When the tingle is gone, begin chewing again, until the tingle returns.
- repeat the process until most of the tingle is gone (about 30 minutes)
- do not eat or drink 15 minutes before chewing the nicotine gum, or while chewing a piece
- to improve your chances of quitting, use at least 9 pieces per day for the first 6 weeks
- if you experience strong or frequent cravings, you may use a second piece within the hour. However, do not continuously use one piece after another since this may cause you hiccups, heartburn, nausea or other side effects.
- do not use more than 24 pieces a day
- It is important to complete treatment. If you feel you need to use the gum for a longer period to keep from smoking, talk to your health care provider.
Other information
Inactive ingredients
Principal Display Panel
*Compare to the active ingredient in Nicorette® Gum
Nicotine Gum
Nicotine Polacrilex gum USP, 2 mg (nicotine)
Stop Smoking Aid
Sugar free
ORIGINAL FLAVOR
PIECES 2 MG EACH
FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE MORE THAN 30 MINUTES OF WAKING UP.
If you smoke your first cigarette WITHIN 30 MINUTES after waking up, use Nicotine Polacrilex Gum USP, 4 mg
TO INCREASE YOUR SUCCESS IN QUITTING:
1. You must be motivated to quit.
2. Use Enough - Use at least 9 Nicotine Polacrilex Gum per day during the first six weeks.
3. Use Long Enough - Use Nicotine Polacrilex Gum for the full 12 weeks.
4. Use With a Support Program as directed in the enclosed User's Guide.
To remove the gum, tear off single unit.
Peel off backing starting at corner with loose edge.
Push gum through foil
- 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
*Nicorette® is a trademark of GlaxoSmithKline Consumer Healthcare, L.P.
This product is not affiliated with GlaxoSmithKline Consumer Healthcare, L.P.
See inside for more details or visit www.nitthehabit.com
BLISTER PACKAGED FOR YOUR PROTECTION. DO NOT USE IF INDIVIDUAL SEALS ARE OPEN OR TORN
Distributed By:
McKesson Corporation dba Sky Packaging
4971 Southridge Blvd. Suite 101, Memphis, TN 38141
INGREDIENTS AND APPEARANCE
| NICOTINE
nicotine polacrilex gum, chewing |
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| Labeler - McKesson Corporation dba SKY Packaging (140529962) |