NDC | 49348-774-09 |
Set ID | f94ae469-4c79-4ce9-9a3d-3bdc645be6d9 |
Category | HUMAN OTC DRUG LABEL |
Packager | Strategic Sourcing Services LLC |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- ACTIVE INGREDIENT
- Purpose
- Uses
- Warnings
-
Do not use
■ this product if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression,
psychiatric or emotional conditions, or Parkinson’s Disease), or for 2 weeks after stopping the
MAOI drug. If you are uncertain whether your prescription drug contains an MAOI, ask a health
professional. - Ask a doctor before use if you have
- Stop use and ask a doctor if
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SUNMARK CHEST CONGESTION RELIEF PE PE
guaifenesin/phenylephrine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49348-774 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin 400 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) LACTOSE (UNII: J2B2A4N98G) MALTODEXTRIN (UNII: 7CVR7L4A2D) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) MINERAL OIL (UNII: T5L8T28FGP) POVIDONE (UNII: FZ989GH94E) MAGNESIUM SILICATE (UNII: 9B9691B2N9) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color white Score 2 pieces Shape OVAL Size 17mm Flavor Imprint Code RCCGPE;C27 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49348-774-09 1 in 1 CARTON 08/29/2019 1 50 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 06/05/2006 Labeler - Strategic Sourcing Services LLC (116956644) Registrant - Reese Pharmaceutical Co (004172052) Establishment Name Address ID/FEI Business Operations Reese Pharmaceutical Co 004172052 relabel(49348-774) , repack(49348-774)