NDC | 55111-272-01, 55111-272-02, 55111-272-05, 55111-272-24, 55111-272-50, 55111-273-01, 55111-273-02, 55111-273-05, 55111-273-24, 55111-273-40, 55111-273-50 |
Set ID | aca5d497-fbc6-464d-2dee-25c50e11bc78 |
Category | HUMAN OTC DRUG LABEL |
Packager | Dr.Reddy's Laboratories Limited |
Generic Name | |
Product Class | |
Product Number | |
Application Number | ANDA075168 |
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each tablet/caplet)
- Purposes
- Uses
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Warnings
Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
- hives
- asthma (wheezing)
- skin reddening
- facial swelling
- shock
- 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 NSAID's (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
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, or kidney disease
- you are taking a diuretic
- you have problems or serious side effects from taking pain relievers or fever reducers
- you have asthma
Ask a doctor or pharmacist before use if you are
- under a doctor's care for any serious condition
- taking any other drug
When using this product
- take with food or milk if stomach upset occurs
- the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
Stop use and ask a doctor if
- you experience any of the following signs ofstomach 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 feels like the pill is stuck in your throat
- redness or swelling is present in the painful area
- any new symptoms appear
-
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 1 tablet/caplet every 8 to 12 hours while symptoms last
- for the first dose you may take 2 tablets/caplets within the first hour
- do not exceed 2 tablets/caplets in any 8- to 12-hour period
- do not exceed 3 tablets/caplets in a 24-hour period
Children under 12 years - ask a doctor
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
- PRINCIPAL DISPLAY PANEL
- Tablets
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
NAPROXEN SODIUM
naproxen sodium tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55111-272 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Naproxen Sodium (UNII: 9TN87S3A3C) (Naproxen - UNII:57Y76R9ATQ) Naproxen Sodium 220 mg Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 2 (UNII: L06K8R7DQK) hypromelloses (UNII: 3NXW29V3WO) magnesium stearate (UNII: 70097M6I30) cellulose, microcrystalline (UNII: OP1R32D61U) Polyethylene Glycol, Unspecified (UNII: 3WJQ0SDW1A) povidone (UNII: FZ989GH94E) talc (UNII: 7SEV7J4R1U) titanium dioxide (UNII: 15FIX9V2JP) POLYSORBATE 80 (UNII: 6OZP39ZG8H) Product Characteristics Color WHITE Score no score Shape ROUND Size 9mm Flavor Imprint Code R;272 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55111-272-24 1 in 1 CARTON 07/29/1998 1 24 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:55111-272-50 1 in 1 CARTON 07/29/1998 2 50 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:55111-272-01 1 in 1 CARTON 07/29/1998 3 100 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:55111-272-02 1 in 1 CARTON 07/29/1998 4 200 in 1 BOTTLE; Type 0: Not a Combination Product 5 NDC:55111-272-05 1 in 1 CARTON 07/29/1998 5 500 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 ANDA075168 07/29/1998 NAPROXEN SODIUM
naproxen sodium tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55111-273 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Naproxen Sodium (UNII: 9TN87S3A3C) (Naproxen - UNII:57Y76R9ATQ) Naproxen Sodium 220 mg Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 2 (UNII: L06K8R7DQK) hypromelloses (UNII: 3NXW29V3WO) magnesium stearate (UNII: 70097M6I30) cellulose, microcrystalline (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) povidone (UNII: FZ989GH94E) talc (UNII: 7SEV7J4R1U) titanium dioxide (UNII: 15FIX9V2JP) POLYSORBATE 80 (UNII: 6OZP39ZG8H) Product Characteristics Color WHITE Score no score Shape CAPSULE Size 12mm Flavor Imprint Code R;273 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55111-273-24 1 in 1 CARTON 07/29/1998 1 24 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:55111-273-50 1 in 1 CARTON 07/29/1998 2 50 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:55111-273-01 1 in 1 CARTON 07/29/1998 3 100 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:55111-273-02 1 in 1 CARTON 07/29/1998 4 200 in 1 BOTTLE; Type 0: Not a Combination Product 5 NDC:55111-273-40 1 in 1 CARTON 07/29/1998 5 400 in 1 BOTTLE; Type 0: Not a Combination Product 6 NDC:55111-273-05 1 in 1 CARTON 07/29/1998 6 500 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 ANDA075168 07/29/1998 Labeler - Dr.Reddy's Laboratories Limited (650562841)