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- NDC Code(s): 68210-4137-1
- Packager: Spirit Pharmaceuticals LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated December 7, 2023
If you are a consumer or patient please visit this version.
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- SPL UNCLASSIFIED SECTION
Drug Facts
- ACTIVE INGREDIENT
Naproxen sodium 220 mg
(naproxen 200 mg) (NSAID)*
*nonsteroidal anti-inflammatory drug
- PURPOSE
Pain reliever/
fever reducer
- Uses
- temporarily relieves minor aches and pain due to :
- backache
- headache
- menstrul cramps
- minor pain of arthritis
- muscular aches
- the common cold
- toothache
- temporarily reduces fever
- WARNINGS
Warnings
Allergy alert
Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
- asthma (wheezing)
- blisters
- facial swelling
- hives
- rash
- shock
- skin reddening
If an allergic reaction occurs, stop use and seek medical help right away.
Stomach bleeding warning
This product contains a non steroidal anti-inflammatory drug(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
NSAID's except aspirin increases 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 surgery
- Ask a doctor before use if
- the stomach bleeding warning applies to you
- you have a history of stomach problems,such as a 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 conditions
- taking any other drug
- taking aspirin for heart attack or stroke, because
- naproxen may decrease this benefit of aspirin
- When using this product
- take with food or milk if stomach upset occurs
- Stop use and ask a doctor if
- you experience any of following sign of stomach bleeding:
- feel faint
- vomit blood
- have bloody or black stools
- have stomach pain that does not get better
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- you have difficulty swallowing
- it feel like the pill is stuck in your throat
- redness or swelling is present in the painful area
- any new symptoms appear
- PREGNANCY OR BREAST FEEDING
If pregnant or breast feeding, ask a health profession 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 complication during the delivery.
- KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children. In case of overdose, get medical help or contact a position control center right away (1-800-222-1222)
- Directions
- 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 one tablet every 8 to 12 hours while symptoms last
- for the first dose you may take within the first hour
- do not exceed 2 tablets in any 8 to 12 hours period
- do not exceed 3 tablets in 24 hour period
Children under 12 years:
- Ask a doctor
- Other information
each tablet contains: sodium 20 mg
store between 20°-25°C(68-77°F). 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*, maize starch*, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate*,stearic acid*, titanium dioxide.
*contains one or more of these ingredients - QUESTIONS
Questions or comments?
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- PRINCIPAL DISPLAY PANEL
- INGREDIENTS AND APPEARANCE
NAPROXEN SODIUM
naproxen sodium tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68210-4137 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN SODIUM 220mg Inactive Ingredients Ingredient Name Strength MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POVIDONE K30 (UNII: U725QWY32X) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color blue (light blue) Score no score Shape OVAL (biconvex) Size 4mm Flavor Imprint Code ET9 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68210-4137-1 1 in 1 CARTON 04/28/2021 1 10 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207612 03/23/2020 Labeler -Spirit Pharmaceuticals LLC(179621011)
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More Info on this Drug
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NAPROXEN SODIUM tablet, film coated
Number of versions: 7
| Published Date (What is this?) | Version | Files |
|---|---|---|
| Dec 8, 2023 | 7 (current) | download |
| Jun 7, 2023 | 6 | download |
| Nov 29, 2022 | 5 | download |
| Oct 25, 2021 | 4 | download |
| Sep 15, 2021 | 3 | download |
| Jun 17, 2021 | 2 | download |
| Apr 29, 2021 | 1 | download |
RxNorm
NAPROXEN SODIUM tablet, film coated
| RxCUI | RxNorm NAME | RxTTY | |
|---|---|---|---|
| 1 | 849574 | naproxen sodium 220 MG Oral Tablet | PSN |
| 2 | 849574 | naproxen sodium 220 MG Oral Tablet | SCD |
| 3 | 849574 | naproxen sodium 220 MG (as naproxen 200 MG) Oral Tablet | SY |
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NDC Codes
NAPROXEN SODIUM tablet, film coated
If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.
| NDC | |
|---|---|
| 1 | 68210-4137-1 |
