Active ingredient(s)
For Tablets:
Active ingredient (in each tablet)
Naproxen sodium 220 mg
(naproxen 200 mg) (NSAID)*
*nonsteroidal anti-inflammatory drug
For Caplets:
Active ingredient (in each caplet)
Naproxen sodium 220 mg
(naproxen 200 mg) (NSAID)*
*nonsteroidal anti-inflammatory drug
Uses
temporarily relieves minor aches and pains due to:
• minor pain of arthritis
• muscular aches
• backache
• menstrual cramps
• headache
• toothache
• the common cold
temporarily reduces fever
Warnings
Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
• hives
• facial swelling
• asthma (wheezing)
• shock
• skin reddening
• rash
• blisters
If an allergic reaction occurs, stop use and seek medical help right away.
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding.
The chance is higher if you:
• are age 60 or older
• have had stomach ulcers or bleeding problems
• take a blood thinning (anticoagulant) or steroid drug
• take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
• have 3 or more alcoholic drinks every day while using this product
• take more or for a longer time than directed
Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.
Do not use
• if you have ever had an allergic reaction to any other pain reliever/fever reducer
• right before or after heart surgery
Ask a doctor before use if
• the stomach bleeding warning applies to you
• you have a history of stomach problems, such as heartburn
• you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
• you are taking a diuretic
• you have problems or serious side effects from taking pain relievers or fever reducers
Ask a doctor or pharmacist before use if you are
• under a doctor's care for any serious condition
• taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin
• taking any other drug
Stop use and ask doctor if
you experience any of the following signs of stomach bleeding:
• feel faint
• vomit blood
• have bloody or black stools
• have stomach pain that does not get better
you have symptoms of heart problems or stroke:
• chest pain
• trouble breathing
• weakness in one part or side of body
• slurred speech
• leg swelling
pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
you have difficulty swallowing
it feels like the pill is stuck in your throat
redness or swelling is present in the painful area
any new symptoms appear
If pregnant or breast-feeding,
ask a health professional before use. It is especially important not to use naproxen sodium at 20 weeks or later in 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. (1-800-222-1222)
Directions
For Tablets:
• do not take more than directed
• the smallest effective dose should be used
• drink a full glass of water with each dose
| Adults and children 12 years and older | • take 1 tablet every 8 to 12 hours while symptoms last • for the first dose you may take 2 tablets within the first hour • do not exceed 2 tablets in any 8- to 12-hour period • do not exceed 3 tablets in a 24-hour period |
| Children under 12 years | • ask a doctor |
For Caplets:
• do not take more than directed
• the smallest effective dose should be used
• drink a full glass of water with each dose
| Adults and children 12 years and older | • take 1 caplet every 8 to 12 hours while symptoms last • for the first dose you may take 2 caplets within the first hour • do not exceed 2 caplets in any 8- to 12-hour period • do not exceed 3 caplets in a 24-hour period |
| Children under 12 years | • ask a doctor |
Other information
For Tablets:
• each tablet contains: sodium 20 mg
• store at 20-25ºC (68-77ºF).
• avoid high humidity and excessive heat above 40°C (104°F).
For Caplets:
• each caplet contains: sodium 20 mg
• store at 20-25ºC (68-77ºF).
• avoid high humidity and excessive heat above 40°C (104°F).
Inactive ingredients
colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2 Lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide
Questions or comments?
call toll free 1-877-376-4271
Manufactured for:
Time-Cap Labs, Inc.
7 Michael Avenue, Farmingdale,
NY 11735, USA
Manufactured by:
Marksans Pharma Ltd.
Plot No. L-82, L-83,
Verna Indl. Estate,
Verna, Goa - 403722, India.
Mfg. Lic. No.: GO/DRUGS/515
Principal Display Panel
NDC 25000-141-43
Naproxen Sodium Tablets, USP 220 mg
10’s count bottle label
NDC 25000-141-43
Naproxen Sodium Tablets, USP 220 mg
10’s count carton label
NDC 25000-141-02
Naproxen Sodium Tablets, USP 220 mg
24’s count bottle label
NDC 25000-141-02
Naproxen Sodium Tablets, USP 220 mg
24’s count carton label
NDC 25000-141-14
Naproxen Sodium Tablets, USP 220 mg
1000’s count bottle label
NDC 25000-144-14
Naproxen Sodium Tablets, USP 220 mg (Capsule-shaped tablet)
1000’s count bottle label
NDC 25000-144-43
Naproxen Sodium Tablets, USP 220 mg (Capsule-shaped tablet)
10’s count bottle label
NDC 25000-144-43
Naproxen Sodium Tablets, USP 220 mg (Capsule-shaped tablet)
10’s count carton label
NDC 25000-144-02
Naproxen Sodium Tablets, USP 220 mg (Capsule-shaped tablet)
24’s count bottle label
NDC 25000-144-02
Naproxen Sodium Tablets, USP 220 mg (Capsule-shaped tablet)
24’s count carton label
