Drug Facts (continued)
`Inactive ingredients FD&C Blue #1, FD&C Yellow
`#5, gelatin, glycerin, lactic acid, mannitol, pharmaceutical
`ink, polyethylene glycol, povidone, propylene glycol,
`purified water, sorbitan, sorbitol
`Questions or comments?
`call toll free 1-800-447-1140
`
`Drug Facts (continued)
`If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen
`sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause
`problems in the unborn child or complications during delivery.
`Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
`Directions n do not take more than directed n the smallest effective dose should be used n do not take
`longer than 10 days, unless directed by a doctor (see Warnings) n drink a full glass of water with each dose
`n if taken with food, this product may take longer to work
`n take 1 capsule every 8 to 12 hours while symptoms last
`adults and children
`n for the first dose you may take 2 capsules within the first hour
`12 years and older:
`n do not exceed 2 capsules in any 8- to 12- hour period
`n do not exceed 3 capsules in a 24 hour period
`children under 12 years:
`n ask a doctor
`Other information n each capsule contains: sodium 20 mg n contains color additives including FD&C
`Yellow No. 5 (tartrazine) n store at 20°-25°C (68°-77°F) avoid high humidity and excessive heat above 40°C
`(104°F) n do not use if carton is open or if Tamper-Evident seal under bottle cap imprinted with "Sealed for Your
`Protection" is broken or missing. n read all directions and warnings before use. Keep carton.
`
`NDC 00000-000-00
`
`See new warnings information.
`
`Naproxen Sodium
`Capsules, 220 mg
`
`Pain Reliever/Fever Reducer (NSAID)
`
`15 Capsules*
`*Each Liquid-filled capsule contains 200 mg naproxen
`
`Drug Facts
`Active ingredient (in each capsule) Purposes
`Naproxen Sodium 220 mg (naproxen 200 mg) (NSAID)*.............................................Pain reliever/fever reducer
`*nonsteroidal anti-inflammatory drug
`Uses
`n temporarily relieves minor aches and pains due to:
` headache n muscular aches n minor pain of arthritis n toothache n backache n
`
` the common cold n menstrual cramps n
`
`n temporarily reduces fever
`Warnings
`Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin.
`Symptoms may include: n hives n facial swelling n asthma (wheezing) n shock n skin reddening
`n rash n blisters If an allergic reaction occurs, stop use and seek medical help right away.
`Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach
`bleeding. The chance is higher if you: n are age 60 or older n have had stomach ulcers or bleeding problems n take a
`blood thinning (anticoagulant) or steroid drug n take other drugs containing an NSAID [aspirin, ibuprofen, naproxen, or
`others] n have 3 or more alcoholic drinks every day while using this product n take more or for a longer time than directed
`
`Drug Facts (continued)
`Do not use n if you have ever had an allergic reaction to any other pain reliever/fever reducer
`n right before or after heart surgery
`Ask a doctor before use if you have n problems or serious side effects from taking pain relievers or fever reducers
`n stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain n ulcers n bleeding
`problems n high blood pressure n heart or kidney disease n taken a diuretic n reached age 60 or older
`Ask a doctor or pharmacist before use if you are n taking any other drug containing an NSAID (prescription or
`nonprescription) n taking a blood thinning (anticoagulant) or steroid drug
`n under a doctor’s care for any serious condition n taking any other drug
`When using this product n take with food or milk if stomach upset occurs
`n long term continuous use may increase the risk of heart attack or stroke
`Stop use and ask a doctor if n you feel faint, vomit blood, or have bloody or black stools. These are signs of
`stomach bleeding. n pain gets worse or lasts more than 10 days n fever gets worse or lasts more than 3 days
`n stomach pain or upset gets worse or lasts n redness or swelling is present in the painful area n any new
`symptoms appear n you have difficulty swallowing n it feels like the capsule is stuck in your throat
`n you develop heartburn
`
`
`PP#
`I2of5
`
`Lot #
`Expiration Date
`Rev # 2/06
`
`
`
`
`
`
`
`
`
`
`
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`
` 4125 Premier Drive
` High Point NC 27265
`
`Manufactured by: Banner Pharmacaps Inc.
`
`------
`
`-----------
`
`-- ------------
`-- -----------
`
`------
`
`--- ----
`
`-- ---
`
`--------------
`-- --------------------
`--- ------------ ----
`---- --
`--- -----
`
`-
`
`---
`-------------------------------
`
`-----
`
`--------
`
`(b)(4)
`------------------------- ------- ------ -- ---- ------------------ -- --------------
`------------------------------ - -- -------------------------
`------- -------------------------
`
`-----
`
`- -----
`
`--------------
`-------------------------------
`----- -------------------------------
`
`-----------
`-------------
`------------ ------------
`--- --------------------------------
`-------------------------- --------------------------------------------------------------------- ----- ---------------------------
`------ --------------- -------- --------------------------------------------- ---- ------------------------------------------
`------ ----------------------------------
`----------------------------------- --------------------------------------------------- ------------------------------------
`--- --------------------------- ------------------------------------------------------ --------- ------------------------------
`------------- ----------------------------- -------------- ------------------------- ---------- - ---------------------------
`---- ---------- ---------------------
`
`------------
`-------
`
`-------- - ---------
`
`-------
`
`
`Inactive ingredients FD&C Blue #1, FD&C Yellow
`#5, gelatin, glycerin, lactic acid, mannitol, pharmaceutical
`ink, polyethylene glycol, povidone, propylene glycol,
`purified water, sorbitan, sorbitol
`Questions or comments?
`call toll free 1-800-447-1140
`
`Drug Facts (continued)
`If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen
`sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause
`problems in the unborn child or complications during delivery.
`Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
`Directions n do not take more than directed n the smallest effective dose should be used n do not take
`longer than 10 days, unless directed by a doctor (see Warnings) n drink a full glass of water with each dose
`n if taken with food, this product may take longer to work
`n take 1 capsule every 8 to 12 hours while symptoms last
`adults and children
`n for the first dose you may take 2 capsules within the first hour
`12 years and older:
`n do not exceed 2 capsules in any 8- to 12- hour period
`n do not exceed 3 capsules in a 24 hour period
`children under 12 years:
`n ask a doctor
`Other information n each capsule contains: sodium 20 mg n contains color additives including FD&C
`Yellow No. 5 (tartrazine) n store at 20°-25°C (68°-77°F) avoid high humidity and excessive heat above 40°C
`(104°F) n do not use if carton is open or if Tamper-Evident seal under bottle cap imprinted with "Sealed for Your
`Protection" is broken or missing. n read all directions and warnings before use. Keep carton.
`
`NDC 00000-000-00
`
`See new warnings information.
`
`Naproxen Sodium
`Capsules, 220 mg
`
`Pain Reliever/Fever Reducer (NSAID)
`
`15 Capsules*
`*Each Liquid-filled capsule contains 200 mg naproxen
`
`Drug Facts
`Active ingredient (in each capsule) Purposes
`Naproxen Sodium 220 mg (naproxen 200 mg) (NSAID)*.............................................Pain reliever/fever reducer
`*nonsteroidal anti-inflammatory drug
`Uses
`n temporarily relieves minor aches and pains due to:
` headache n muscular aches n minor pain of arthritis n toothache n backache n
`
` the common cold n menstrual cramps n
`
`n temporarily reduces fever
`Warnings
`Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin.
`Symptoms may include: n hives n facial swelling n asthma (wheezing) n shock n skin reddening
`n rash n blisters If an allergic reaction occurs, stop use and seek medical help right away.
`Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach
`bleeding. The chance is higher if you: n are age 60 or older n have had stomach ulcers or bleeding problems n take a
`blood thinning (anticoagulant) or steroid drug n take other drugs containing an NSAID [aspirin, ibuprofen, naproxen, or
`others] n have 3 or more alcoholic drinks every day while using this product n take more or for a longer time than directed
`
`Drug Facts (continued)
`Do not use n if you have ever had an allergic reaction to any other pain reliever/fever reducer
`n right before or after heart surgery
`Ask a doctor before use if you have n problems or serious side effects from taking pain relievers or fever reducers
`n stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain n ulcers n bleeding
`problems n high blood pressure n heart or kidney disease n taken a diuretic n reached age 60 or older
`Ask a doctor or pharmacist before use if you are n taking any other drug containing an NSAID (prescription or
`nonprescription) n taking a blood thinning (anticoagulant) or steroid drug
`n under a doctor’s care for any serious condition n taking any other drug
`When using this product n take with food or milk if stomach upset occurs
`n long term continuous use may increase the risk of heart attack or stroke
`Stop use and ask a doctor if n you feel faint, vomit blood, or have bloody or black stools. These are signs of
`stomach bleeding. n pain gets worse or lasts more than 10 days n fever gets worse or lasts more than 3 days
`n stomach pain or upset gets worse or lasts n redness or swelling is present in the painful area n any new
`symptoms appear n you have difficulty swallowing n it feels like the capsule is stuck in your throat
`n you develop heartburn
`
`
`PP#
`I2of5
`
`Lot #
`Expiration Date
`Rev # 2/06
`
`
`
`
`
`
`
`
`
`
`
`
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`
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`
`
`
`
`
`
`
`
`
`
` 4125 Premier Drive
` High Point NC 27265
`
`Manufactured by: Banner Pharmacaps Inc.
`
`------
`
`-----------
`
`-- ------------
`-- -----------
`
`------
`
`--- ----
`
`-- ---
`
`--------------
`-- --------------------
`--- ------------ ----
`---- --
`--- -----
`
`-
`
`---
`-------------------------------
`
`-----
`
`--------
`
`(b)(4)
`------------------------- ------- ------ -- ---- ------------------ -- --------------
`------------------------------ - -- -------------------------
`------- -------------------------
`
`-----
`
`- -----
`
`--------------
`-------------------------------
`----- -------------------------------
`
`-----------
`-------------
`------------ ------------
`--- --------------------------------
`-------------------------- --------------------------------------------------------------------- ----- ---------------------------
`------ --------------- -------- --------------------------------------------- ---- ------------------------------------------
`------ ----------------------------------
`----------------------------------- --------------------------------------------------- ------------------------------------
`--- --------------------------- ------------------------------------------------------ --------- ------------------------------
`------------- ----------------------------- -------------- ------------------------- ---------- - ---------------------------
`---- ---------- ---------------------
`
`------------
`-------
`
`-------- - ---------
`
`-------
`
`
`
`Rev # 2/06
`Expiration Date
`Lot #
`
`Manufactured by: Banner Pharmacaps Inc.
`
` High Point NC 27265
` 4125 Premier Drive
`
`
`
`
`
`
`
`
`
`
`
`
`
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`older:
`years and
`children 12
`adults and
`longer to work
`with food,this product may take
`water with each dose n if taken
`Warnings) n drink a full glass of
`unless directed by a doctor (see
`n do not take longer than 10 days,
`effective dose should be used
`than directed n the smallest
`Directions n do not take more
`Stomach bleeding warning
`Allergy alert
`WARNINGS AND PRODUCT INFORMATION
`KEEP OUTER CARTON FOR COMPLETE
`Warnings
`cramps n temporarily reduces fever
`n the common cold n menstrual
`arthritis n toothache n backache
`n muscular aches n minor pain of
`aches and pains due to: n headache
`Uses n temporarily relieves minor
`*nonsteroidal anti-inflammatory drug
`(NSAID)*..................... fever reducer
`(naproxen 200 mg) Pain reliever/
`Naproxen Sodium 220 mg
`(in each capsule)
`Active ingredient Purposes
`
`n ask a doctor
`in a 24 hour period
`n do not exceed 3 capsules
`in any 8- to 12-hour period
`n do not exceed 2 capsules
`the first hour
`may take 2 capsules within
`n for the first dose you
`last
`12 hours while symptoms
`n take 1 capsule every 8 to
`
`12 years:
`children under
`
`NDC 00000-000-00
`See new warnings information.
`Naproxen Sodium
`Capsules, 220 mg
`
`Pain Reliever/Fever Reducer
`(NSAID)
`
`15 Capsules*
`
`*Each Liquid-filled capsule
`contains 200 mg naproxen
`
`------
`
`-----------
`
`-- ------------
`-- -----------
`
`------
`
`--- ----
`
`-- ---
`
`(b)(4)
`------------------------- ------- ------ -- ---- ------------------ -- --------------
`------------------------------ - -- -------------------------
`------- -------------------------
`
`-----------
`-------------
`------------ ------------
`--- --------------------------------
`-------------------------- --------------------------------------------------------------------- ----- ---------------------------
`------ --------------- -------- --------------------------------------------- ---- ------------------------------------------
`------ ----------------------------------
`----------------------------------- --------------------------------------------------- ------------------------------------
`--- --------------------------- ------------------------------------------------------ --------- ------------------------------
`------------- ----------------------------- -------------- ------------------------- ---------- - ---------------------------
`---- ---------- ---------------------
`
`------------
`-------
`
`-------- - ---------
`
`-------
`
`--------------
`-- --------------------
`--- ------------ ----
`---- --
`--- -----
`
`-
`
`---
`---------------
`
`-----
`
`--------
`
`-----
`
`- -----
`
`
`
`FRONT
`
`Rev # 2/06
`Expiration Date
`Lot #
`
`PEEL
`HERE
`
`Drug Facts Continued on back of label
`
`Manufactured by: Banner Pharmacaps Inc.
`
` High Point NC 27265
` 4125 Premier Drive
`
`
`
`
`
`
`
`
`
`
`
`
`
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`
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`
`
` n backache n the common cold n menstrual cramps
` n headache n muscular aches n minor pain of arthritis n toothache
`
`
`
`
`
`n temporarily relieves minor aches and pains due to:
`Uses
`*nonsteroidal anti-inflammatory drug
`(NSAID)*.........................................................................Pain reliever/fever reducer
`Naproxen Sodium 220 mg (naproxen 200 mg)
`Active ingredient (in each capsule) Purposes
`Drug Facts
`
`n long term continuous use may increase the risk of heart attack or stroke
`When using this product n take with food or milk if stomach upset occurs
`condition n taking any other drug
`thinning (anticoagulant) or steroid drug n under a doctor’s care for any serious
`containing an NSAID (prescription or nonprescription) n taking a blood
`Ask a doctor or pharmacist before use if you are n taking any other drug
`n taken a diuretic n reached age 60 or older
`n bleeding problems n high blood pressure n heart or kidney disease
`back, such as heartburn, upset stomach, or stomach pain n ulcers
`taking pain relievers or fever reducers n stomach problems that last or come
`Ask a doctor before use if you have n problems or serious side effects from
`fever reducer n right before or after heart surgery
`Do not use n if you have ever had an allergic reaction to any other pain reliever/
`more or for a longer time than directed
`n have 3 or more alcoholic drinks every day while using this product n take
`other drugs containing an NSAID [aspirin, ibuprofen, naproxen, or others]
`problems n take a blood thinning (anticoagulant) or steroid drug n take
`higher if you: n are age 60 or older n have had stomach ulcers or bleeding
`inflammatory drug (NSAID), which may cause stomach bleeding. The chance is
`Stomach bleeding warning: This product contains a nonsteroidal anti-
`If an allergic reaction occurs, stop use and seek medical help right away.
`n asthma (wheezing) n shock n skin reddening n rash n blisters
`in people allergic to aspirin. Symptoms may include: n hives n facial swelling
`Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially
`Warnings
`n temporarily reduces fever
`
`
`
`
`
`NDC 00000-000-00
`
`See new warnings information.
`
`Naproxen Sodium
`Capsules, 220 mg
`
`Pain Reliever/Fever Reducer (NSAID)
`200 Capsules*
`
`*Each Liquid-filled capsule
`contains 200 mg naproxen
`
`BACK
`
`
`
`
`
`
`Drug Facts (Continued)
`Stop use and ask a doctor if n you feel faint, vomit blood, or have bloody
`or black stools. These are signs of stomach bleeding. n pain gets worse or
`lasts more than 10 days n fever gets worse or lasts more than 3 days
`n stomach pain or upset gets worse or lasts n redness or swelling is
`present in the painful area n any new symptoms appear n you have
`difficulty swallowing n it feels like the capsule is stuck in your throat
`n you develop heartburn
`If pregnant or breast-feeding, ask a health professional before use. It is
`especially important not to use naproxen sodium during the last 3 months of
`pregnancy unless definitely directed to do so by a doctor because it may
`cause problems in the unborn child or complications during delivery.
`Keep out of reach of children. In case of overdose, get medical help or
`contact a Poison Control Center right away.
`Directions n do not take more than directed
`n the smallest effective dose should be used n do not take longer than
`10 days, unless directed by a doctor (see Warnings) n drink a full glass of
`water with each dose n if taken with food, this product may take longer
`to work
`adults and children
`12 years and older:
`
`
`
`
`
` symptoms last
`
`n take 1 capsule every 8 to 12 hours while
`
`children under 12 years:
`Other information n each capsule contains: sodium 20 mg
`n contains color additives including FD&C Yellow No. 5 (tartrazine)
`n store at 20°-25°C (68°-77°F) avoid high humidity and excessive heat above
`40°C (104°F) n do not use if Tamper-Evident seal under bottle cap is broken or
`missing. n read all directions and warnings before use.
`Inactive ingredients
`FD&C Blue #1, FD&C Yellow #5, gelatin, glycerin, lactic acid, mannitol,
`pharmaceutical ink, polyethylene glycol, povidone, propylene glycol, purified
`water, sorbitan, sorbitol
`Questions or comments? call toll free 1-800-447-1140
`
`n do not exceed 3 capsules in a 24 hour period
`n ask a doctor
`
`
`
`
`
` period
`
`n do not exceed 2 capsules in any 8- to 12- hour
`
`
`
`
`
` within the first hour
`
`n for the first dose you may take 2 capsules
`
`------
`
`------------
`
`-- ------------
`-- -----------
`
`-----
`
`--- ----
`
`-- ---
`
`--------------
`-- --------------------
`--- ------------ ----
`---- --
`--- -----
`
`-
`
`---
`--------------------
`
`-----
`
`--------
`
`(b)(4)
`------------------------- ------- ------ -- ---- ------------------ -- --------------
`------------------------------ - -- -------------------------
`------- -------------------------
`
`-----------
`-------------
`------------ ------------
`--- --------------------------------
`-------------------------- --------------------------------------------------------------------- ----- ---------------------------
`------ --------------- -------- --------------------------------------------- ---- ------------------------------------------
`------ ----------------------------------
`----------------------------------- --------------------------------------------------- ------------------------------------
`--- --------------------------- ------------------------------------------------------ --------- ------------------------------
`------------- ----------------------------- -------------- ------------------------- ---------- - ---------------------------
`---- ---------- ---------------------
`
`------------
`-------
`
`-------- - ---------
`
`-------
`
`-----
`
`- -----
`
`
`
`---------------------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
`---------------------------------------------------------------------------------------------------------------------
` /s/
`---------------------
`Andrea Segal
`2/17/2006 02:39:32 PM
`
`
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