NDC | 49483-609-00, 49483-609-01, 49483-609-05 |
Set ID | 17ecaee0-c1c6-4360-81c1-d6afe50b9b27 |
Category | HUMAN OTC DRUG LABEL |
Packager | TIME CAP LABORATORIES, INC |
Generic Name | |
Product Class | |
Product Number | |
Application Number | ANDA090545 |
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- INDICATIONS & USAGE
- PURPOSE
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WARNINGS
Allergy alerts: 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 an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
are age 60 or older
have bad stomach ulcers or bleeding problems
take a blood thinning (anticoagulant) or steroid drug
take other drug 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. - KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
NAPROXEN SODIUM
naproxen sodium tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49483-609 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN 220 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color blue Score no score Shape ROUND Size 10mm Flavor Imprint Code 141 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49483-609-00 6500 in 1 BAG; Type 0: Not a Combination Product 03/28/2016 2 NDC:49483-609-05 50 in 1 BOTTLE; Type 0: Not a Combination Product 03/28/2016 3 NDC:49483-609-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 03/28/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090545 03/28/2016 Labeler - TIME CAP LABORATORIES, INC (037052099) Registrant - TIME CAP LABORATORIES, INC (037052099) Establishment Name Address ID/FEI Business Operations MARKSANS PHARMA LIMITED 925822975 manufacture(49483-609)