Label: NICOTINE patch
- NDC Code(s): 50090-1148-0, 50090-1694-0, 50090-1697-0
- Packager: A-S Medication Solutions
- This is a repackaged label.
- Source NDC Code(s): 0536-5894, 0536-5895, 0536-5896
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated February 4, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient Step One (in each patch)
- Active ingredient Step Two (in each patch)
- Active ingredient Step Three (in each patch)
- Purpose
- Uses
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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, use nicotine gum, or use nicotine patch 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 skin problems because you are more likely to get rashes.
- 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.
When using this product
- If you have vivid dreams or other sleep disturbances, remove this patch at bedtime
Stop use and ask a doctor if
- Skin redness caused by the patch does not go away after four days, or your skin swells, or you get a rash
- Irregular heartbeat or palpitations occur
- You get symptoms of nicotine overdose, such as nausea, vomiting, dizziness, weakness, and rapid heartbeat
- you have symptoms of an allergic reaction (such as difficulty breathing or rash)
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Directions
- If you are under 18 years of age, ask a doctor before use
- Before using this product, read the enclosed self-help 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 the following schedule:
Weeks 1 thru 4 Weeks 5 and 6 Weeks 7 and 8 STEP 1 STEP 2 STEP 3 use one 21 mg patch/day use one 14 mg patch/day use one 7 mg patch/day - If you smoke 10 or less cigarettes per day, start with Step 2 for 6 weeks, then Step 3 for 2 weeks and then stop
- Apply one new patch every 24 hours on skin that is dry, clean, and hairless
- Remove backing from patch and immediately press onto skin. Hold for 10 seconds.
- Wash hands after applying or removing patch. Save pouch to use for patch disposal. Dispose of used patch by folding sticky ends together and putting in pouch.
- The used patch should be removed and a new one applied to a different skin site at the same time each day
- If you have vivid dreams, you may remove the patch at bedtime and apply a new one in the morning
- 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 8 weeks. If you still feel the need to use the patch talk to your doctor.
- Other information
- Inactive ingredients
- Questions or comments?
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TO INCREASE YOUR SUCCESS IN QUITTING:
1. You must be motivated to quit.
2. Use one patch daily according to directions.
3. It is important to complete treatment.
4. If you feel you need to use the patch for a longer period to keep from smoking, talk to your health care provider.
5. Use patch with a behavioral support program such as the one described in the enclosed booklet.
For your family's protection, patches are supplied in child-resistant pouches. Do not use if individual pouch is open or torn.
- Not for sale to persons 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.
- HOW SUPPLIED
- Nicotine
- Nicotine
- Nicotine
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INGREDIENTS AND APPEARANCE
NICOTINE
nicotine patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50090-1148(NDC:0536-5895) Route of Administration TRANSDERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE 14 mg in 24 h Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50090-1148-0 14 in 1 CARTON 11/28/2014 1 1 h in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074612 10/20/1997 NICOTINE
nicotine patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50090-1694(NDC:0536-5894) Route of Administration TRANSDERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE 7 mg in 24 h Inactive Ingredients Ingredient Name Strength Dimethicone (UNII: 92RU3N3Y1O) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50090-1694-0 14 in 1 CARTON 02/18/2020 02/18/2020 1 1 h in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074612 10/20/1997 02/18/2020 NICOTINE
nicotine patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50090-1697(NDC:0536-5896) Route of Administration TRANSDERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE 21 mg in 24 h Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50090-1697-0 14 in 1 CARTON 02/13/2015 1 1 h in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074612 10/20/1997 Labeler - A-S Medication Solutions (830016429) Establishment Name Address ID/FEI Business Operations A-S Medication Solutions 830016429 RELABEL(50090-1148, 50090-1694, 50090-1697)
