Safrel Mucus Relief
FDA Label NDC 71309-460

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Safrel Pharmaceuticals, Llc. for the product Safrel Mucus Relief (NDC 71309-460). 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, otc - active ingredient, otc - purpose, indications & usage, 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

Otc - Active Ingredient

Active ingredient (in each extended-release tablet)

Guaifenesin 600 mg

Otc - Purpose

Purpose

Expectorant

Indications & Usage

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 right away (1-800-222-1222).

Dosage & Administration

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

Storage And Handling

Other information

  • store between 20°-25°C (68°-77°F)

Inactive Ingredient

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

Otc - Questions

Questions or comments?

Call 1-844-384-3723

Package Label.Principal Display Panel

Safrel Mucus Relief

Guaifenesin Extended-Release Tablets 600 mg

Expectorant

12 Hour

Relieves Chest Congestion

Thins and Loosens Mucus

Immediate and Extended Release

100 Extended-Release Tablets

500 Extended-Release Tablets

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