Label: MOOREBRAND PHENYLEPHRINE- phenylephrine hydrochloride tablet, film coated
- NDC Code(s): 55670-163-13
- Packager: Moore Medical LLC
- 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 March 29, 2022
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SPL UNCLASSIFIED SECTION
Drug Facts
Uses
Temporarily relieves
■ nasal congestion due to the common cold, hay fever or other upper respiratory allergies
■ sinus congestion and pressure
Promotes nasal and/or sinus drainage
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
Stop use and ask a doctor if
■ you get nervous, dizzy, or sleepless
■ symptoms do not improve within 7 days or are accompanied by fever
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Adults and children: (12 years and older) Take 2 tablets every 4 hours. Do not take more than 12 tablets in 24 hours.
Other information
■ read all product information before using
■ store at room temperature 59º-86º F (15º-30º C)
■ tamper evident sealed packets
■ do not use any opened or torn packets
- Moore Medical Phenylephrine Label
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INGREDIENTS AND APPEARANCE
MOOREBRAND PHENYLEPHRINE
phenylephrine hydrochloride tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55670-163 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE (UNII: J2B2A4N98G) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Product Characteristics Color red (red) Score no score Shape ROUND (ROUND) Size 7mm Flavor Imprint Code 271 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55670-163-13 500 in 1 BOX 12/30/2008 12/31/2024 1 2 in 1 PACKET; 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 12/30/2008 12/31/2024 Labeler - Moore Medical LLC (051420107) Registrant - Unifirst First Aid Corporsation (832947092)
