Chloresin
FDA Label NDC 51532-0107

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Affasco Inc. for the product Chloresin (NDC 51532-0107). 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 - ask doctor, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

Active Ingredients (In Each Tablet)

Acetaminophen 325 mg, Dextromethorphan HBr 15 mg, Guaifenesin 200 mg, Phenylephrine HCl 5 mg

Otc - Purpose

Pain reliever/fever reducer, Cough suppressant, Expectorant, Nasal decongestant

Indications & Usage

Uses: For temporary relief of:

• cough • sore throat • minor aches • pain

• headaches • nasal congestion • fever

• helps loosen phlegm (mucus), thin bronchial secretions to make coughs more productive

Warnings

Warnings:

Liver Warning:

This product contains acetaminophen. Severe liver damage may occur if you take more than 8 tablets in 24 hours, if you take with other drugs containing acetaminophen (prescription or nonprescription), or if you have 3 or more alcoholic drinks every day while using this product.

Otc - Ask Doctor

Ask a doctor before use if you have: heart disease, high blood pressure, thyroid disease, diabetes, trouble urinating due to an enlarged prostate gland, cough that occurs with too much phlegm (mucus), chronic cough that lasts such as occurs with smoking, asthma, or emphysema or chronic bronchitis.

Otc - Stop Use

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 signsof a serious condition.

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.

Overdosage

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Dosage & Administration

Directions: Do not use more than directed.

Adults and children: (12 years and older) Take 2 tablets with water every 6-8 hours as needed. Do not take more than 8 tablets in 24 hours, or as directed by doctor.

Children: (under 12 years) Do use unless directed by a doctor.

Inactive Ingredient

SEE ORIGINAL BOX FOR COMPLETE PRODUCT INFORMATION

Package Label.Principal Display Panel

Affascochloresin12-16 (Afassco Chloresin)

Affascochloresin12-16 (Afassco Chloresin)

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