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Drug Facts
DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
Pseudoephedrine Hydrochloride Tablet
FDA Label NDC 70000-0601
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health 110, Llc Dba Leader for the product Pseudoephedrine Hydrochloride (NDC 70000-0601). 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 other, active ingredient (in each tablet), purpose, uses, otc - do not use, ask a doctor before use if you have, otc - when using, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Tablet)
Pseudoephedrine HCl, USP 120 mg
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
Otc - Do Not Use
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
Otc - When Using
When using this product do not exceed recommended dosage
Stop Use And Ask A Doctor If
- nervousness, dizziness, or sleeplessness occur
- symptoms do not improve within 7 days or occur with a fever
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
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. (1-800-222-1222)
Directions
| adults and children 12 years and over |
|
| children under 12 years | do not use this product in children under 12 years of age |
Other Information
- store at 59° to 77° F in a dry place. Protect from light
- TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
Inactive Ingredients
castor oil, colloidal silicon dioxide, hypromellose, microcrystalline cellulose, magnesium stearate, titanium dioxide
Questions?
call 1-800-406-7984
Principal Display Panel - 120 Mg Tablet Blister Pack Carton
NDC 70000-0601-1
LEADER™
Maximum Strength | Non-Drowsy
Pseudoephedrine
Pseudoephedrine HCl, 120 mg
Extended-Release Tablets, USP
Long-Acting Nasal Decongestant
12 Hour
Sinus Pressure + Congestion
COMPARE TO
SUDAFED® 12 HOUR
active ingredient
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20 COATED CAPSULE
SHAPED TABLETS
Principal Display Panel (120 mg Tablet Blister Pack Carton)
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