Label: XPECT DECONGESTANT- phenylephrine tablet
- NDC Code(s): 42961-205-01, 42961-205-02
- Packager: Cintas Corporation
- 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 April 13, 2021
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
Temporarily relieves nasal congestion due to:
• Common cold, hay fever or other upper respiratory allergies
• Sinus congestion and pressure helps decongest sinus openings and passages
• Temporarily restores free breathing through the nose
3. Warning(s) (c)(5)
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 MAOI drug. If you do not know if your prescription drug contains an MAOI, consult 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 enlarged prostate gland
When using this product do not exceed recommended dose
Stop using and ask doctor if:
• Nervousness, dizziness or sleeplessness occur
• Symptoms do not improve within 7 days or are accompanied by fever
• New symptoms occur
If pregnant or breast-feeding, ask health professional before use.
Keep out of reach of children
In case of overdose, get medical help or contact a Poison Control Center right away. - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
XPECT DECONGESTANT
phenylephrine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42961-205 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE 5 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C RED NO. 27 (UNII: 2LRS185U6K) PHOSPHATE ION (UNII: NK08V8K8HR) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) POLYDEXTROSE (UNII: VH2XOU12IE) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color red Score no score Shape ROUND Size 7mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42961-205-02 80 in 1 BOX 02/27/2021 1 NDC:42961-205-01 2 in 1 PACKET; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 02/27/2021 Labeler - Cintas Corporation (056481716)

