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NDC 49035-0196-02 Nicotine 7 mg/24h Details
Nicotine 7 mg/24h
Nicotine is a TRANSDERMAL PATCH, EXTENDED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by Wal-Mart Stores Inc. The primary component is NICOTINE.
MedlinePlus Drug Summary
Nicotine skin patches are used to help people stop smoking cigarettes. They provide a source of nicotine that reduces the withdrawal symptoms experienced when smoking is stopped.
Related Packages: 49035-0196-02Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Nicotine Transdermal Patch
Product Information
| NDC | 49035-0196 |
|---|---|
| Product ID | 49035-196_9e128a5c-86a6-4841-b136-3bc13ecaa7c2 |
| Associated GPIs | 62100005008520 |
| GCN Sequence Number | 016425 |
| GCN Sequence Number Description | nicotine PATCH TD24 7MG/24HR TRANSDERM |
| HIC3 | J3A |
| HIC3 Description | SMOKING DETERRENT AGENTS (GANGLIONIC STIM,OTHERS) |
| GCN | 03421 |
| HICL Sequence Number | 006249 |
| HICL Sequence Number Description | NICOTINE |
| Brand/Generic | Generic |
| Proprietary Name | Nicotine |
| Proprietary Name Suffix | transdermal system |
| Non-Proprietary Name | nicotine |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | PATCH, EXTENDED RELEASE |
| Route | TRANSDERMAL |
| Active Ingredient Strength | 7 |
| Active Ingredient Units | mg/24h |
| Substance Name | NICOTINE |
| Labeler Name | Wal-Mart Stores Inc |
| Pharmaceutical Class | Cholinergic Nicotinic Agonist [EPC], Nicotine [CS] |
| DEA Schedule | n/a |
| Marketing Category | NDA AUTHORIZED GENERIC |
| Application Number | NDA020165 |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 49035-0196-02 (49035019602)
| NDC Package Code | 49035-196-02 |
|---|---|
| Billing NDC | 49035019602 |
| Package | 14 PATCH in 1 CARTON (49035-196-02) / 24 h in 1 PATCH |
| Marketing Start Date | 2010-10-19 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL aefd30c4-35d5-425e-855c-327a7c436188 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.
Do not use
- •
- if you continue to smoke, chew tobacco, use snuff, or use a nicotine gum or other nicotine containing products
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.
- •
- an allergy to adhesive tape or have skin problems because you are more likely to get rashes
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.
When using this product
- •
- do not smoke even when not wearing the patch. The nicotine in your skin will still be entering your blood stream for several hours after you take off the patch.
- •
- If you have vivid dreams or other sleep disturbances remove this patch at bedtime
Directions
- •
- if you are under 18 years of age, ask a doctor before use
- •
- before using this product, read the enclosed User’s Guide for complete directions and other information
- •
- stop smoking completely when you begin using the patch
- •
- if you smoke more than 10 cigarettes per day, use according to the following 10 week schedule:
|
STEP 1 |
STEP 2 |
STEP 3 |
|
Use one 21mg patch/day |
Use one 14mg patch/day |
Use one 7mg patch/day |
|
Weeks 1-6 |
Weeks 7-8 |
Weeks 9-10 |
- •
- if you smoke 10 or less cigarettes per day, do not use STEP 1 (21mg). Start with STEP 2 (14mg) for 6 weeks, then STEP 3 (7mg) for 2 weeks and then stop.
- •
- steps 2 and 3 allow you to gradually reduce your level of nicotine. Completing the full program will increase your chances of quitting successfully.
- •
- apply one new patch every 24 hours on skin that is dry, clean and hairless. Save pouch for disposing of the patch after use
- •
- remove backing from patch and immediately press onto skin. Hold for 10 seconds.
- •
- wash hands after applying or removing patch. Throw away the patch by folding sticky ends together. Replace in its pouch and discard. See enclosed User’s Guide for safety and handling.
- •
- you may wear the patch for 16 or 24 hours.
- •
- if you crave cigarettes when you wake up, wear the patch for 24 hours.
- •
- if you have vivid dreams or other sleep disturbances, you may remove the patch at bedtime and apply a new one in the morning
- •
- the used patch should be removed and a new one applied to a different skin site at the same time each day
- •
- do not wear more than one patch at a time
- •
- do not cut patch in half or into smaller pieces
- •
- do not leave patch on for more than 24 hours because it may irritate your skin and loses strength after 24 hours
- •
- stop using the patch at the end of 10 weeks. If you started with STEP 2, stop using the patch at the end of 8 weeks. If you still feel the need to use the patch, talk to your doctor.
Inactive ingredients
Questions or comments?
call toll-free 1-888-287-1915
For your family's protection, nicotine patches are supplied in child-resistant pouches.
Do not use if individual pouch/packet is damaged or open.
Walmart
If this product is found for sale at a location other than Walmart please call 1-800-WAL-MART.
To increase your success in quitting:
- You must be motivated to quit.
- Complete the full treatment program, applying a new patch every day.
- Use with a support program as described 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.
Free audio CD upon request. See inside.
Satisfaction guaranteed - Or we'll replace it or give you your money back. For questions or comments or to report an undesired reaction or side effect, please call 1-888-287-1915.
Made in Switzerland
Distributed by:
Wal-Mart Stores, Inc.,
Bentonville, AR 72716
© Wal-Mart Stores, Inc.
*NICODERM is a licensed trademark of the GlaxoSmithKline group of companies.
What is the nicotine patch and how is it used?
The nicotine patch is a small, nicotine-containing patch. When you put on a nicotine patch, nicotine passes through the skin and into your body. The nicotine patch is very thin and uses special material to control how fast nicotine passes through the skin. Unlike the sudden jolts of nicotine delivered by cigarettes, the amount of nicotine you receive remains relatively smooth throughout the 24 or 16 hour period you wear the nicotine patch. This helps to reduce cravings you may have for nicotine.
Read carton and enclosed User’s Guide before using this product. Keep the carton and User’s Guide.
They contain important information
READ THE LABEL
PRINCIPAL DISPLAY PANEL
NDC 49035-194-02
Clear
Nicotine
Transdermal
System
equate®
Compare to NicoDerm® CQ®*
21mg Delivered Over 24 hours
Stop Smoking Aid
Includes User's Guide with behavior support program enrollment form
If you smoke more than 10 cigarettes per day, start with Step 1
If you smoke 10 or less cigarettes per day, start with Step 2
21 mg
14 PATCHES
STEP 1
100224XA
PRINCIPAL DISPLAY PANEL
NDC 49035-195-02
Clear
Nicotine
Transdermal
System
equate®
Compare to NicoDerm® CQ®*
14mg Delivered Over 24 hours
Stop Smoking Aid
Includes User's Guide with behavior support program enrollment form
If you smoke more than 10 cigarettes per day, start with Step 1
If you smoke 10 or less cigarettes per day, start with Step 2
14 mg
14 PATCHES
STEP 2
100222XA
PRINCIPAL DISPLAY PANEL
NDC 49035-196-02
Clear
Nicotine
Transdermal
System
equate®
Compare to NicoDerm® CQ®*
7mg Delivered Over 24 hours
Stop Smoking Aid
Includes User's Guide
For use after completing Step 2
If you smoke more than 10 cigarettes per day, start with Step 1
If you smoke 10 or less cigarettes per day, start with Step 2
7 mg
14 PATCHES
STEP 3
100352XA
INGREDIENTS AND APPEARANCE
| NICOTINE
TRANSDERMAL SYSTEM
nicotine patch, extended release |
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TRANSDERMAL SYSTEM
nicotine patch, extended release |
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TRANSDERMAL SYSTEM
nicotine patch, extended release |
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| Labeler - Wal-Mart Stores Inc (051957769) |