Label: GNP MUCUS RELIEF PE- guaifenesin/phenylephrine tablet
- NDC Code(s): 46122-700-71
- Packager: AmerisourceBergen Drug Corp
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated July 14, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- Purpose
-
Uses
Temporarily relieves symptoms associated with a cough ,the common cold,hay fever or other upper respiratory allergies.
- helps loosen phlegm (mucus)
- clear nasal passageways
- loosens nasal congestion
- drain bronchial tubes
- shrinks swollen membranes
- clears stuffy nose
- makes coughs more productive
- thin bronchial secretions
- 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
- Carton Panel
-
INGREDIENTS AND APPEARANCE
GNP MUCUS RELIEF PE
guaifenesin/phenylephrine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:46122-700 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) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) 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) SODIUM LAURYL SULFATE (UNII: 368GB5141J) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color white Score 2 pieces Shape OVAL Size 18mm Flavor Imprint Code PH043 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46122-700-71 1 in 1 CARTON 01/13/2022 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 01/13/2022 Labeler - AmerisourceBergen Drug Corp (007914906) Registrant - Reese Pharmaceutical Co (004172052) Establishment Name Address ID/FEI Business Operations Pharbest 557054835 manufacture(46122-700)