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Nicotine Transdermal System 21 Mg Delivered Over 24 Hours PATCH STOP SMOKING AID 21Mg STEP 1

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Nicotine Transdermal System 21 Mg Delivered Over 24 Hours PATCH STOP SMOKING AID 21Mg STEP 1 Nicotine Transdermal System 21 mg delivered over 24 hours PATCH STOP SMOKING AID 21mg STEP 1 8 DO NOT OPEN POUCH UNTIL READY TO USE. DIRECTIONS: Apply one patch to a dry, clean, hairless portion of upper body or arms. Refer to Self-Help Guide for detailed directions. DO NOT CUT PATCH. KEEP OUT OF REACH OF CHILDREN AND PETS. Used patches have enough nicotine to poison children and pets. If swallowed, get medical help or contact a Poison Control Center right away. Save pouch to use for patch disposal. Dispose of the used patch by folding sticky TO OPEN CUT ALONG DOTTED LINE 43598-448-71 ends together and putting in pouch. Store at 20-25˚C (68-77˚F). 3 DO NOT USE IF INDIVIDUAL POUCH IS OPEN OR TORN, OR IF PATCH IS CUT. Distributed by: ¢ Dr. Reddy’s Laboratories, Inc. Princeton, NJ 08540 EXP LOT 300024595 Final CLabels rton or Container Labels U/AU/A Pg. Pg 15 2 U/A Pg. 5 Pg. U/A Labeling Final 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. NDC XXXXX-XXX-XX Nicotine Transdermal System 21 mg delivered over 24 hours PATCH STOP SMOKING AID 21 mg Includes: Behavior Support Program with self-help guide 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 The full course for STEP 1 is 28 patches 2 (4 weeks), this package contains 2 patches only. Read the enclosed self-help guide for PATCHES additional information. Distributed by: • Not for sale to persons under 18 years of age. Dr. Reddy's Laboratories, Inc. • Proof of age required. Princeton, NJ 08540 • Not for sale in vending machines or from any source where proof of age cannot be verified. Weekdays (9am-8pm ET) or visit us at www.habitrol.com at us visit or ET) (9am-8pm Weekdays patches by folding sticky ends together and putting in pouch. in putting and together ends sticky folding by patches Comments or Questions? or Comments patches are protection, your family’s For 1-800-585-8682 Call Save pouch to use for patch disposal. Dispose of the used used the of Dispose disposal. patch for use to pouch Save supplied in child-resistant pouches. Do not use if individual pouch is medical help or contact a Poison Control Center right away. away. right Center Control Poison a contact or help medical polyester, cellulose paper, methacrylic acid copolymer acid methacrylic paper, cellulose polyester, enough nicotine to poison children and pets. If swallowed, get get swallowed, If pets. and children poison to nicotine enough Inactive ingredients Inactive acrylate adhesive, aluminized aluminized adhesive, acrylate Keep out of reach of children and pets. and children of reach of out Keep Used patches have have patches Used Other information Other breathing or rash) or breathing store at 20-25°C (68-77°F) 20-25°C at store • open or torn. UPC you have symptoms of an allergic reaction (such as difficulty as (such reaction allergic an of symptoms have you • to your health care provider. care health your to vomiting, dizziness, weakness and rapid heartbeat rapid and weakness dizziness, vomiting, use the patch for a longer period to keep from smoking, talk talk smoking, from keep to period longer a for patch the use you get symptoms of nicotine overdose, such as nausea, as such overdose, nicotine of symptoms get you • it is important to complete treatment. If you feel you need to to need you feel you If treatment. complete to important is it • irregular heartbeat or palpitations occur palpitations or heartbeat irregular • any MRI (magnetic resonance imaging) procedures imaging) resonance (magnetic MRI any four days, or if your skin swells, or you get a rash a get you or swells, skin your if or days, four to avoid possible burns, remove patch before undergoing undergoing before patch remove burns, possible avoid to • skin redness caused by the patch does not go away after away go not does patch the by caused redness skin • may irritate your skin and loses strength after 24 hours 24 after strength loses and skin your irritate may Stop use and ask a doctor if doctor a ask and use Stop do not leave patch on for more than 24 hours because it it because hours 24 than more for on patch leave not do • this patch at bedtime at patch this do not cut patch in half or into smaller pieces smaller into or half in patch cut not do • if you have vivid dreams or other sleep disturbances remove disturbances sleep other or dreams vivid have you if • do not wear more than one patch at a time a at patch one than more wear not do • When using this product this using When bedtime and apply a new one in the morning the in one new a apply and bedtime Your prescription dose may need to be adjusted. be to need may dose prescription Your if you have vivid dreams, you may remove the patch at at patch the remove may you dreams, vivid have you if • taking a prescription medicine for depression or asthma. or depression for medicine prescription a taking • a different skin site at the same time each day each time same the at site skin different a using a non-nicotine stop smoking drug smoking stop non-nicotine a using • the used patch should be removed and a new one applied to to applied one new a and removed be should patch used the • Ask a doctor or pharmacist before use if you are you if use before pharmacist or doctor a Ask folding sticky ends together and putting in pouch. in putting and together ends sticky folding history of seizures. of history • use for patch disposal. Dispose of the used patches by by patches used the of Dispose disposal. patch for use stomach ulcer or diabetes. or ulcer stomach • wash hands after applying or removing patch. Save pouch to to pouch Save patch. removing or applying after hands wash • you are more likely to get rashes. get to likely more are you skin. Hold for 10 seconds. 10 for Hold skin. an allergy to adhesive tape or have skin problems, because problems, skin have or tape adhesive to allergy an • remove backing from patch and immediately press onto onto press immediately and patch from backing remove • can increase your blood pressure. blood your increase can clean and hairless and clean high blood pressure not controlled with medication. Nicotine medication. with controlled not pressure blood high • apply one new patch every 24 hours on skin that is dry, dry, is that skin on hours 24 every patch new one apply • can increase your heart rate. heart your increase can Nicotine Step 3 Step 2 for 2 weeks 2 for for 6 weeks, then then weeks, 6 for See self-help guide inside. heart disease, recent heart attack, or irregular heartbeat. irregular or attack, heart recent disease, heart • Step Step day, per cigarettes less or 10 start with with start smoke you if • Ask a doctor before use if you have you if use before doctor a Ask patch/day patch/day patch/day the risks to your child from this medicine are not fully known. fully not are medicine this from child your to risks the use one 7 mg 7 one use mg 14 one use use one 21 mg 21 one use medicine. This medicine is believed to be safer than smoking. However, However, smoking. than safer be to believed is medicine This medicine. STEP 3 STEP 2 STEP STEP 1 STEP your child. Try to stop smoking without using any nicotine replacement replacement nicotine any using without smoking stop to Try child. your the advice of your health care provider. care health your of advice the Smoking can seriously harm harm seriously can Smoking Weeks 7 and 8 and 7 Weeks 6 and 5 Weeks 4 thru 1 Weeks If you are pregnant or breast-feeding, only use this medicine on on medicine this use only breast-feeding, or pregnant are you If Warnings following schedule below: schedule following more than 10 cigarettes per day, per cigarettes 10 than more use the the use smoke you if • craving, associated with quitting smoking. quitting with associated craving, begin using the patch on your quit day quit your on patch the using begin • Use reduces withdrawal symptoms, including nicotine including symptoms, withdrawal reduces for complete directions and other information other and directions complete for Nicotine, 21 mg delivered over 24 hours.... Stop smoking aid smoking Stop hours.... 24 over delivered mg 21 Nicotine, before using this product, read the enclosed self-help guide guide self-help enclosed the read product, this using before • Purpose patch) each (in If you are under 18 years of age, ask a doctor before use before doctor a ask age, of years 18 under are you If • Directions Active ingredient ingredient Active Drug Facts Drug Drug Facts Facts Drug (continued) Font & Format Specifications Font Name: Helvetica Neue LT Std 77 Bold Condensed Ob ique 10 point type Font Name Helvetica Neue LT Std 77 Bold Condensed Oblique / Helvetica Neue LT Std 57 Condensed 8 point type Font Name: Helvetica Neue LT Std 77 Bold Condensed Ob ique 8 point type Font Name: Helvetica Neue LT Std 77 Bold Condensed 6 point type Font Name: Helvetica Neue LT Std 57 Condensed 6 point type Font Name: Helvetica Neue LT Std 57 Condensed 5 point type Yes 0 100% 6.5 pt.
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