Label: PHENAZOPYRIDINE HYDROCHLORIDE tablet, coated
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Contains inactivated NDC Code(s)
NDC Code(s): 61919-098-10 - Packager: DirectRX
- This is a repackaged label.
- Source NDC Code(s): 42937-702
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated December 9, 2015
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- Clinical Pharmacology
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- Contraindications
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- Dosage and Adminisrtation
- Overdosage
- Package Label
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INGREDIENTS AND APPEARANCE
PHENAZOPYRIDINE HYDROCHLORIDE
phenazopyridine hydrochloride tablet, coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61919-098(NDC:42937-702) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENAZOPYRIDINE HYDROCHLORIDE (UNII: 0EWG668W17) (PHENAZOPYRIDINE - UNII:K2J09EMJ52) PHENAZOPYRIDINE HYDROCHLORIDE 200 mg Inactive Ingredients Ingredient Name Strength MINERAL OIL (UNII: T5L8T28FGP) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYPROMELLOSES (UNII: 3NXW29V3WO) POVIDONES (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color brown (Reddish-brown) Score no score Shape ROUND Size 10mm Flavor Imprint Code 702 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61919-098-10 10 in 1 BOTTLE; Type 0: Not a Combination Product 12/09/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 12/09/2015 Labeler - DirectRX (079254320) Establishment Name Address ID/FEI Business Operations DirectRX 079254320 repack(61919-098)
