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

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6.5 pt. 6.5 .5 pt. .5

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6 point type point 6 Font Name: Helvetica Neue LT Std 57 Condensed Condensed 57 Std LT Neue Helvetica Name: Font

6 point type point 6 Font Name: Helvetica Neue LT Std 77 Bold Condensed Condensed Bold 77 Std LT Neue Helvetica Name: Font

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Drug Facts Drug Facts (continued) Active ingredient Directions (in each patch) Purpose • If you are under 18 years of age, ask a doctor before use Nicotine, 21 mg delivered over 24 hours.... Stop smoking aid • before using this product, read the enclosed self-help guide for complete directions and other information reduces withdrawal symptoms, including nicotine Use • begin using the patch on your quit day craving, associated with quitting smoking. • if you smoke more than 10 cigarettes per day, use the Warnings following schedule below: If you are pregnant or breast-feeding, only use this medicine on the advice of your health care provider. Smoking can seriously harm Weeks 1 thru 4 Weeks 5 and 6 Weeks 7 and 8 your child. Try to stop smoking without using any nicotine replacement STEP 1 STEP 2 STEP 3 medicine. This medicine is believed to be safer than smoking. However, use one 21 mg use one 14 mg use one 7 mg the risks to your child from this medicine are not fully known. patch/day patch/day patch/day Ask a doctor before use if you have • heart disease, recent heart attack, or irregular heartbeat. • if you smoke 10 or less cigarettes per day, start with Step guide inside. guide See self-help See Nicotine can increase your heart rate. 2 for 6 weeks, then Step 3 for 2 weeks • high blood pressure not controlled with medication. Nicotine • apply one new patch every 24 hours on skin that is dry, can increase your blood pressure. clean and hairless • an allergy to adhesive tape or have skin problems, because • remove backing from patch and immediately press onto you are more likely to get rashes. skin. Hold for 10 seconds. • stomach ulcer or diabetes. • wash hands after applying or removing patch. Save pouch to • history of seizures. use for patch disposal. Dispose of the used patches by folding sticky ends together and putting in pouch. Ask a doctor or pharmacist before use if you are • the used patch should be removed and a new one applied to • using a non-nicotine stop smoking drug a different skin site at the same time each day • taking a prescription medicine for depression or asthma. • if you have vivid dreams, you may remove the patch at Your prescription dose may need to be adjusted. bedtime and apply a new one in the morning When using this product • do not wear more than one patch at a time • if you have vivid dreams or other sleep disturbances remove • do not cut patch in half or into smaller pieces this patch at bedtime • do not leave patch on for more than 24 hours because it Stop use and ask a doctor if may irritate your skin and loses strength after 24 hours • skin redness caused by the patch does not go away after • to avoid possible burns, remove patch before undergoing four days, or if your skin swells, or you get a rash any MRI (magnetic resonance imaging) procedures • irregular heartbeat or palpitations occur • it is important to complete treatment. If you feel you need to • you get symptoms of nicotine overdose, such as nausea, use the patch for a longer period to keep from smoking, talk vomiting, dizziness, weakness and rapid heartbeat to your health care provider. • you have symptoms of an allergic reaction (such as difﬁculty UPC open or torn. breathing or rash) Other information • store at 20-25°C (68-77°F) Keep out of reach of children and pets. Used patches have Inactive ingredients acrylate adhesive, aluminized enough nicotine to poison children and pets. If swallowed, get polyester, cellulose paper, methacrylic acid copolymer medical help or contact a Poison Control Center right away. Do not use if individual pouch is supplied in child-resistant pouches. Save pouch to use for patch disposal. Dispose of the used Call 1-800-585-8682 For your family’s protection, patches are protection, family’s your For Comments or Questions?

patches by folding sticky ends together and putting in pouch. Weekdays (9am-8pm ET) or visit us at www.habitrol.com

source where proof of age cannot be veriﬁed. be cannot age of proof where source

• Not for sale in vending machines or from any any from or machines vending in sale for Not •

• Proof of age required. age of Proof • Princeton, NJ 08540 NJ Princeton,

Dr. Reddy's Laboratories, Inc. Laboratories, Reddy's Dr. • Not for sale to persons under 18 years of age. of years 18 under persons to sale for Not •

Distributed by: Distributed

additional information. additional PATCHES

only. Read the enclosed self-help guide for for guide self-help enclosed the Read only.

(4 weeks), this package contains 2 patches patches 2 contains package this weeks), (4

The full course for STEP 1 is 28 patches patches 28 is 1 STEP for course full The

PER DAY: START WITH STEP 2 STEP WITH START DAY: PER

LESS CIGARETTES OR 10 SMOKE YOU IF

PER DAY: START WITH STEP 1 STEP WITH START DAY: PER

MORE THAN 10 CIGARETTES CIGARETTES 10 THAN SMOKE YOU IF

self-help guide self-help

Program Program with

Behavior Support Behavior

Includes:

21 mg 21

PATCH STOP SMOKING AID SMOKING STOP

delivered over 24 hours 24 over delivered mg 21

Nicotine Transdermal System Transdermal Nicotine

NDC XXXXX-XXX-XX NDC

5. Use patch with a behavioral support program, such as the one described in the enclosed booklet. enclosed the in described one the as such program, support behavioral a with patch Use 5.

4. If you feel you need to use the patch for a longer period to keep from smoking, talk to your health care provider. care health your to talk smoking, from keep to period longer a for patch the use to need you feel you If 4.

3. It is important to complete treatment. complete to important is It 3.

2. Use one patch daily according to directions. to according daily patch one Use 2.

1. You must be motivated to quit. to motivated be must You 1. TO INCREASE YOUR SUCCESS IN QUITTING: IN SUCCESS YOUR INCREASE TO

U/A Pg. 12 Pg. U/A Labeling Final