Active Ingredients
ACONITUM NAPELLUS 3X HPUS
CHAMOMILLA 3X HPUS
BELLADONA 3X HPUS
Abc Liquid
FDA Label NDC 60986-2035
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Marco Pharma International Llc for the product Abc (NDC 60986-2035). 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 ingredients, inactive ingredient, otc - purpose, warnings, indications & usage, dosage & administration, 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
Inactive Ingredient
ETHYL ALCOHOL (20% BY VOL) AND WATER
Otc - Purpose
FOR TEMPORARY RELIEF OF COLD AND FLU SYMPTOMS WITH TEMPERATURE
Warnings
KEEP OUT OF REACH OF CHILDREN
IF PREGNANT OR BREAST-FEEDING, CONSULT A HEALTH PROFESSIONAL BEFORE USE
IF SYMPTOMS PERSIST MORE THAN A FEW DAYS, CONTACT LICENSED PRACTIONER.
Indications & Usage
FOR TEMPORARY RELIEF OF EARACHE
Dosage & Administration
ADULTS AND CHILDREN: DAY 1; TAKE 5 DROPS ON THE TONGUE EVERY 15 MINUTES FOR 2 HOURS. THEN TAKE 5 DROPS ONCE EVERY HOUR. DAY 2; TAKE 5 DROPS ONCE EVERY HOUR. DAY 3; TAKE 5 DROPS EVERY TWO HOURS. CONTINUE WITH 10 DROPS THREE TIMES DAILY
* Please review the disclaimer below.
