Crcle Guaifenesin Extended-release Tablets, 600 Mg Tablet
FDA Label NDC 57483-270

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Innovus Pharmaceuticals, Inc. for the product Crcle Guaifenesin Extended-release Tablets, 600 Mg (NDC 57483-270). 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 ingredient, purpose, uses, warnings, do not use, ask a doctor before use if you have, stop use and ask a doctor if, if pregnant or breast-feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Guaifenesin 600 mg (for 600 mg)
Guaifenesin 1200 mg (for 1200 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

Do Not Use

  • for children under 12 years of age

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)

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.

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 (1-800-222-1222)

Directions

  • do not crush, chew, or break tablet
  • take with a full glass of water
  • this product can be administered without regard for 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. (For 600mg)
  • adults and children 12 years of age and over: 1 tablet every 12 hours. Do not exceed 2 tablets in 24 hours.(For 1200mg)
  • children under 12 years of age: do not use

Other Information

Tamper evident: Do not use if carton is open or if printed seal on blister is broken or missing.

store between 20-25°C (68-77°F)

Inactive Ingredients

carbomer homopolymer type B; hypromellose, Lake of FD&C Blue 1, magnesium stearate, microcrystalline cellulose; sodium starch glycolate

Questions?

Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST.

* Please review the disclaimer below.