Mucus Relief Tablet, Extended Release
FDA Label NDC 80513-403

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Advanced Rx Llc for the product Mucus Relief (NDC 80513-403). 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 other, active ingredient(in each extended-release tablet), purpose, uses, warnings, otc - do not use, otc - ask doctor, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Distributed by:

ADVANCED RX LLC

1942 NE 163rd St North Miami Beach,

FL 33162 U.S.A

Active Ingredient(In Each Extended-Release Tablet)

Guaifenesin 600 mg

Purpose

Expectorant

Uses

■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

Warnings

Otc - Do Not Use

Do not use

■ for children under 12 years of age

Otc - Ask Doctor

Ask a doctor before use if you have

■ persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

■ cough accompanied by too much phlegm (mucus)

Otc - Stop Use

Stop use and ask a doctor if

■ cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

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.In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

■ do not crush, chew, or break tablet

■ take with a full glass of water

■ this product can be administered without regard for the timing of meals

■ adults and children 12 years of age and over:1 or 2 tablets every 12 hours. Do not exceed 4 tablets in 24 hours.

■ children under 12 years of age:do not use

Other Information

■ store between 20° to 25°C (68° to 77°F)

■ DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED

Inactive Ingredients

carbomer homopolymer type B, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate.

Questions?

Call toll-free 1-800-630-8895

Principal Display Panel

NDC 80513-403-20

*Compare to the active ingredient in Mucinex ®

Mucus Relief

Guaifenesin 600 mg

Expectorant

EXTENDED-RELEASE TABLETS BI-LAYER TABLETS

200 Tablets

*This product is not manufactured or distributed by the owner of the registered trademark Mucinex ®Extended-Release 600 mg Tablets

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