Active Ingredient
Pseudoephedrine HCl 60 mg
Pseudoephedrine Hydrochloride
FDA Label NDC 54868-1973
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Physicians Total Care, Inc. for the product Pseudoephedrine Hydrochloride (NDC 54868-1973). 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, 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 pregrant 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
- temporarily relieves sinus congestion and pressure
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
- diabetes
- thyroid disease
- heart disease
- high blood pressure
- trouble urinating due to enlargement of the prostate gland
When Using This Product
- do not exceed recommended dose
Stop Use And Ask A Doctor If
- nervousness, dizziness, or sleeplessness occur
- symptoms do not improve within 7 days or occur with fever
If Pregrant 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
- adults and children 12 years and older: take 1 tablet every 4 to 6 hours. Do not take more than 4 tablets in 24 hours.
- children under 12 years of age: do not use
Other Information
- store at controlled room temperature 15˚-30˚C (59˚-86˚F)
- see end flap for expiration date and lot number
Inactive Ingredients
corn starch, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, stearic acid
Principal Display Panel
The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available
FOR PHARMACY USE ONLY.
NOT FOR RETAIL SALE.
NDC 54868-1973-1
Image Of Package Label (1973)
Pseudoephedrine Hydrochloride 60 mg
NASAL DECONGESTANT 60 mg
Relieves Nasal and Sinus Congestion due to Colds or Hay Fever
Without Drowsiness
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
50844 Rev. 0807L11302
Distributed by Major Pharmaceuticals
31778 Enterprise Drive
Livonia, MI 48150 USA M-17
Rev. 10/10 Re-order No. 700324
Relabeing and Repackaging by:
Physicians Total Care, Inc.
Tulsa, Oklahoma 74146
* Please review the disclaimer below.
