Label: NASAL AND SINUS DECONGESTANT tablet
-
Contains inactivated NDC Code(s)
NDC Code(s): 71105-333-68 - Packager: Redicare LLC
- Category: HUMAN OTC DRUG LABEL
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 2, 2021
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient (in each tablet)........................................................ Purpose
- Uses:
-
Warnings:
Do not use:
■ more than recommended dose ■ 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 MAOI drug. If you do not know if your prescription drug contains a MAOI, consult a doctor or pharmacist before taking this product.
- Ask a doctor before use if you have:
- If pregnant or breast-feeding a baby,
- KEEP OUT OF REACH OF CHILDREN.
- Directions:
- Other Information:
- Inactive Ingredients:
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
NASAL AND SINUS DECONGESTANT
nasal and sinus decongestant tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71105-333 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 CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C RED NO. 28 (UNII: 767IP0Y5NH) CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE (UNII: FZ989GH94E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color pink Score no score Shape ROUND Size 6mm Flavor Imprint Code FR4 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71105-333-68 100 in 1 CARTON; Type 0: Not a Combination Product 10/01/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 02/01/2017 Labeler - Redicare LLC (800149346)