Facol Classic One
FDA Label NDC 72689-0013

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Oasis Trading for the product Facol Classic One (NDC 72689-0013). 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, otc - keep out of reach of children, indications & usage, warnings, inactive ingredient, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Acetaminophen, Guaifenesin, Pseudoephedrine Hydrochloride, DL-Methylephedrine Hydrochloride, Cloperastine Hydrochloride, Chlorpheniramine Maleate

Otc - Purpose

relieve your cold symptoms

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

Indications & Usage

■ adult and children 12 years of age and older: 2 capsules every 5 hours
■ children under 12 years of age: ask a doctor

Warnings

Warnings
When using this product
Do not use for a period longer than 1 weeks
Stop use and ask a doctor if nervousness, dizziness, or sleepness occur. Pain, nasal congestion or cough gets worse or lasts more than 7 days.
fever gets worse or lasts more than 3 days
New symptoms occur
These may be signs of a serious condition.
If pregnant 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

Inactive Ingredient

camauba wax cellulose, starch

Dosage & Administration

For oral use only

* Please review the disclaimer below.