Label: REFENESEN CHEST CONGESTION RELIEF PE- guaifenesin/phenylephrine tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 10956-381-09, 10956-381-50 - Packager: REESE PHARMACEUTICAL CO.
- 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 September 25, 2014
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
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DO NOT USE
Do not use this product if you are now taking a prescription Monoamine Oxidase inhibitor ; MAIO,
certain drugs for depression,psychiatric or emotional conditions, or Parkinsons Disease or for 2 weeks
after stopping the MAIO drug,if you are uncertain whether your prescription contains an MAIO ,
ask a health professional.
- ASK DOCTOR
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
REFENESEN CHEST CONGESTION RELIEF PE
guaifenesin/phenylephrine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10956-381 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) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) MINERAL OIL (UNII: T5L8T28FGP) POVIDONE (UNII: FZ989GH94E) HYPROMELLOSES (UNII: 3NXW29V3WO) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM LAURYL SULFATE (UNII: 368GB5141J) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) Product Characteristics Color white Score 2 pieces Shape OVAL Size 19mm Flavor Imprint Code PH043 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10956-381-50 1 in 1 CARTON 1 50 in 1 BOTTLE, PLASTIC 2 NDC:10956-381-09 1 in 1 CARTON 2 100 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 09/25/2014 Labeler - REESE PHARMACEUTICAL CO. (004172052) Registrant - REESE PHARMACEUTICAL CO. (004172052) Establishment Name Address ID/FEI Business Operations REESE PHARMACEUTICAL CO. 004172052 repack(10956-381) , relabel(10956-381)