Otc - Active Ingredient
Each tablet contains: Phenylephrine HCl 10 mg
Pseudo Time Pe Tablet, Film Coated
FDA Label NDC 49483-234
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Time Cap Laboratories, Inc. for the product Pseudo Time Pe (NDC 49483-234). 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 otc - active ingredient, inactive ingredient, otc - keep out of reach of children, otc - purpose, indications & usage, dosage & administration, warnings, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
INACTIVE INGREDIENTS: CARNAUBA WAX, CROSCARMELLOSE SODIUM, DIBASIC CALCIUM PHOSPHATE DIHYDRATE, FD-C RED#40 ALUMINUM LAKE, FD-C YELLOW#6 ALUMINUM LAKE, HYPROMELLOSE, MAGNESIUM STEARATE, MICROCRYSTALLINE CELLULOSE, POLYETHYLENE GLYCOL (PEG) 400, STEARIC ACID, TITANIUM DIOXIDE
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.
Otc - Purpose
PURPOSE: nasal decongestant
Indications & Usage
Uses:
Temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies and nasal congestion associated with sinsitis
Temporarily relieves sinus congestion and pressure
Dosage & Administration
DIRECTIONS:
Take every 4 hours; Do not take more than 6 doses in 24 hours; Adults and children 12 years of age and over; 1 tablet
Children under 12 years of ge; ask a doctor
Warnings
WARNINGS;
Do not use if you are 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.
Package Label.Principal Display Panel
234label (234r)
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