Ephed Plus Liquid
FDA Label NDC 65193-180

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 Ephed Plus Liquid (NDC 65193-180). 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 warnings, otc - purpose, indications & usage, otc - keep out of reach of children, otc - pregnancy or breast feeding, dosage & administration, inactive ingredient, otc - active ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Warnings

Warnings

Otc - Purpose

Purpose: Bronchodilator, Expectorant

Indications & Usage

Uses  for temporary relief of mild symptoms of intermittent asthma:  wheezing
tightness of chest , shortness of breath , helps loosen phlegm (mucus) and thin
bronchial secretions to rid bronchial passageways of bothersome mucus, and to make
coughs more productive

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.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health
professional before use

Dosage & Administration

Directions do not take more than directed

­ adults and children 12 years of age and over: take 1

bottle every 4 hours as needed. Do not take more than

6 bottles in 24 hours ­ children under 12 years of age:

do not use

Inactive Ingredient

Inactive ingredients Blue #1, Citric Acid,
Filtered Water, Malic Acid, Natural and Artificial Flavors,
Potassium Sorbate, Propylene Glycol, Sodium

Otc - Active Ingredient

Ephedrine HCI 25 mg, Bronchodilator
Guaifenesin 400 mg, Expectorant

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