Otc - Active Ingredient
In each tablet Pseudoephedrine HCl 30 mg
Pseudo-time
FDA Label NDC 49483-016
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 (NDC 49483-016). 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, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, 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
Otc - Purpose
Nasal Decongestant
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away
Indications & Usage
INDICATIONS AND USAGE:
Temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies, and nasal congestion associated with sinusitis
Temporarily relieves sinus congestion and pressure
Warnings
WARNINGS: 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.
Dosage & Administration
DOSAGE AND ADMINISTRATION:
Directions – take every 4-6 hours -Do not take more than 4 does in 24 hours
Adults and children 12 years and over – 2 tablets
Children 6 to under 12 years – 1 tablet
Children under 6 years – ask a doctor
Inactive Ingredient
INACTIVE INGREDIENTS: acacia, calcium sulfate, carnauba Wax. colloidal silicon dioxide, corn starch, D-C red no. 27, D-C yellow no.10, FD-C red no.40, FD-C yellow no 6, iron oxide black, iron oxide red, iron oxide yellow (iron oxide ochre) Kaolin, microcrystalline cellulose, polyethylene glycol (PEG) 400, , pregelatinized starch, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide
Package Label.Principal Display Panel
29rlabel (29rlabel)
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