Label: SUDAFED PE CONGESTION- phenylephrine hydrochloride tablet
- NDC Code(s): 50580-546-50, 50580-546-51
- Packager: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
- 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 August 13, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each tablet)
- Purpose
- Uses
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Warnings
Do not use 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 do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- Directions
- Other information
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Inactive ingredients
carnauba wax, D&C yellow no. 10 aluminum lake, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, magnesium stearate, microcrystalline cellulose, modified starch, polyethylene glycol, polyvinyl alcohol, powdered cellulose, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SUDAFED PE CONGESTION
phenylephrine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50580-546 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride 10 mg Inactive Ingredients Ingredient Name Strength carnauba wax (UNII: R12CBM0EIZ) D&C yellow no. 10 aluminum lake (UNII: CQ3XH3DET6) aluminum oxide (UNII: LMI26O6933) FD&C red no. 40 (UNII: WZB9127XOA) FD&C yellow no. 6 (UNII: H77VEI93A8) magnesium stearate (UNII: 70097M6I30) microcrystalline cellulose (UNII: OP1R32D61U) polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A) polyvinyl alcohol, unspecified (UNII: 532B59J990) powdered cellulose (UNII: SMD1X3XO9M) sodium starch glycolate Type A potato (UNII: 5856J3G2A2) talc (UNII: 7SEV7J4R1U) titanium dioxide (UNII: 15FIX9V2JP) Product Characteristics Color RED Score no score Shape ROUND Size 8mm Flavor Imprint Code WL;80;PE Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50580-546-50 1 in 1 CARTON 07/13/2015 1 18 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:50580-546-51 2 in 1 CARTON 07/13/2015 2 18 in 1 BLISTER PACK; 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 07/13/2015 Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)