NDC | 51532-0140-2 |
Set ID | 05d80f93-020c-48a5-b72f-4a91908949b8 |
Category | HUMAN OTC DRUG LABEL |
Packager | Afassco Inc. |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
Warnings:
Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 8 tablets in 24 hours, if you take with other drugs containing acetaminophen (prescription or nonprescription), or if you have 3 or more alcoholic drinks every day while using this product.
- ASK DOCTOR
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- OVERDOSAGE
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
FEDRIN
acetaminophen, phenylephrine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51532-0140 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE 5 Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) POVIDONE (UNII: FZ989GH94E) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) STEARIC ACID (UNII: 4ELV7Z65AP) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) Product Characteristics Color blue Score no score Shape ROUND Size 12mm Flavor Imprint Code FR33 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51532-0140-2 2 in 1 PACKET; Type 0: Not a Combination Product 10/25/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 10/25/2016 Labeler - Afassco Inc. (609982723)