Active Ingredient (In Each Tablet)
Phenylephrine HCl 10 mg
Crane Safety Sinus Decongestant Tablet, Film Coated
FDA Label NDC 73408-990
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Crane Safety Llc for the product Crane Safety Sinus Decongestant (NDC 73408-990). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, uses, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant or breast feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Nasal decongestant
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
When Using This Product
- do not exceed recommended dosage
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
If Pregnant Or Breast Feeding,
ask a 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.
Directions
- do not use more than directed
Adults and children: (12 years and older) Take 1 tablet every 4 hours. Do not take more than 6 doses in 24 hours.
Children under 12 years: Do not give to children under 12 years of age
Other Information
- read all product information before using
- store at room temperature 59°-86° F (15°-30° C)
- tamper evident sealed packets
- do not use any opened or torn packets
Inactive Ingredients
croscarmellose sodium, FD&C red #40, FD&C yellow # 6, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, propylene glycol, silicon dioxide, titanium dioxide
Questions Or Comments?
877.506.4291
Crane Safety Sinus Decongestant Label
Sinus Decongestant
Relieves Sinus Congestion
CRANE Safety®
Pull to Open
Nasal Decongestant
Phenylephrine HCl 10MG
100 Tablets
Tamper Evident
Sealed Packets
* Please review the disclaimer below.
