Label: UNISHIELD SINUS DECONGESTANT- phenylephrine hcl tablet, film coated
- NDC Code(s): 49314-2083-3
- Packager: Unishield
- 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 16, 2022
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
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DO NOT USE
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 DOCTOR
- WHEN USING
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
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Unishield Sinus Decongestant Label
Unishield
Sinus Decongestant
Phenylephrine HCl 10 mg
100 Tablets/ 1 Tablet Per Packet
Pseudoephedrine Free Sinus Relief
Pull To Open
• For sinus headache, pain, pressure, and congestion
Compare active ingredients to:
Sudafed PE®
Registered Trademark of McNeil Consumer Healthcare
Tamper Evident Unit Dose Packets
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INGREDIENTS AND APPEARANCE
UNISHIELD SINUS DECONGESTANT
phenylephrine hcl tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49314-2083 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 TITANIUM DIOXIDE (UNII: 15FIX9V2JP) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C RED NO. 40 (UNII: WZB9127XOA) HYPROMELLOSES (UNII: 3NXW29V3WO) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color red Score no score Shape ROUND Size 7mm Flavor Imprint Code 272 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49314-2083-3 100 in 1 BOX 03/01/2021 1 1 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 03/01/2021 Labeler - Unishield (790677053) Registrant - Unifirst First Aid Corporation (832947092)