NDC | 49483-608-00, 49483-608-01, 49483-608-05 |
Set ID | ab7b7b8e-923b-4dc1-812c-78e85de1bee1 |
Category | HUMAN OTC DRUG LABEL |
Packager | TIME CAP LABORATORIES, INC |
Generic Name | |
Product Class | |
Product Number | |
Application Number | ANDA090545 |
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
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DOSAGE & ADMINISTRATION
do not 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 to12 hours while symptoms lastfor first dose you may take 2 tablets with in the first hours
do not exceed 2 tablets in any 8 to 12 hour perioddo not exceed 3 tablets in a 24 hours period
children under 12 years: ask a doctor
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INDICATIONS & USAGE
temporarily relieves minor aches and pain due to: backache headache menstrual cramps minor pain of arthritis muscular aches the common cold ...
temporarily relieves minor aches and pain due to:
backache
headache
menstrual cramps
minor pain of arthritis
muscular aches
the common cold
toothache
temporarily reduces fever
- 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 ...
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 reddeningIf 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 olderhave bad stomach ulcers or bleeding problemstake a blood thinning (anticoagulant) or steroid drugtake 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:49483-608 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 GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color blue Score no score Shape OVAL Size 12mm Flavor Imprint Code 144 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49483-608-00 6500 in 1 BAG; Type 0: Not a Combination Product 03/28/2016 2 NDC:49483-608-05 50 in 1 BOTTLE; Type 0: Not a Combination Product 03/28/2016 3 NDC:49483-608-01 100 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(49483-608)