Otc - Active Ingredient
Active Ingredient(In Each Tablet): Pseudoephedrine HCl 30 mg, Guaifenesin 200 mg
Pseudo Ephed Plus
FDA Label NDC 65193-325
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dickey Consumer Products Dba Dmd for the product Pseudo Ephed Plus (NDC 65193-325). 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, indications & usage, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purposes - Nassal Decongestant, Expectorant
Indications & Usage
• temporarily relieves nasal congestion due to the common cold • promotes nasal and/or sinus drainage • temporarily relieves sinus congestion and pressure • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
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.
Ask a doctor before use if you have: • heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to an enlarged prostate gland • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema • a cough accompanied by excessive phlegm (mucus)
When using this product • do not use more than directed • intentional abuse of this product can be harmful or fatal
Stop use and ask a doctor if: • you get nervous dizzy or sleepless • cough lasts more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. • symptoms do not get better within 7 days or occur with a fever
Otc - Pregnancy Or Breast Feeding
If pregnant or breast feeding, ask a health proffessional 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.
Dosage & Administration
• adults and children 12 years of age and over: take 2 tablets every 4 to 6 hours; do not exceed 8 tablets in 24 hours • children under 12 years of age: ask a doctor
Inactive Ingredient
Inactive Ingredients: Maltodextrin, Microcrystalline Cellulose, Povidone, Sodium Starch Glycolate, Stearic Acid
* Please review the disclaimer below.
