Guaifenesin And Dextromethorphan Hbr Tablet, Extended Release
FDA Label NDC 57483-114

14 label sections · Submitted to the FDA by Innovus Pharmaceuticals, Inc. · 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 Guaifenesin And Dextromethorphan Hbr (NDC 57483-114). 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 ingredients, purposes, uses, warnings, ask a doctor before use if you have, when using this product, 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 Ingredients

(in each extended-release tablet)

Dextromethorphan Hydrobromide USP 60 mg
Guaifenesin USP 1200 mg

Purposes

Cough suppressant
Expectorant

Uses


  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • temporarily relieves:
    • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
    • the intensity of coughing
    • the impulse to cough to help you get to sleep

Warnings


Do not use

  • for children under 12 years of age
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

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)

When Using This Product


  • do not use more than directed

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

Directions


  • do not crush, chew, or break extended-release tablet
  • take with a full glass of water
  • this product can be administered without regard for timing of meals
  • adults and children 12 years and older: 1 extended-release tablet every 12 hours; not more than 2 extended-release tablets in 24 hours
  • children under 12 years of age: do not use

Other Information


  • store at 20° to 25°C (68° to 77°F)

Inactive Ingredients


colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize)

Questions?

call 1-855-274-4122

Distributed By:
Innovus Pharmaceuticals, Inc.
5740 Kietzke Lane #300
Reno, Nevada 89511

www.crclehealth.com

Made in India

Package Label-Principal Display Panel - 1200 Mg/60 Mg Blister Carton 28 (4 X 7) Unit-Dose Tablets

Compare to the active
ingredients of Maximum
Strength Mucinex® DM*

NDC 57483-114-28

C˙rcle™

Maximum Strength
Mucus Relief DM
Dextromethorphan HBr 60 mg - Cough Suppressant
Guaifenesin 1200 mg - Expectorant
Extended-release Tablets

 RELIEVES COUGH &
CHEST CONGESTION

12
Hour

  •  Controls cough
  •   Thins & loosens
    mucus

    •  28 (4 x 7) EXTENDED-RELEASE TABLETS

    63
    Actual Size


    Package Label-principal Display Panel (1200 mg/60 mg Blister Carton 28 (4 x 7) Unit-dose Tablets)

    Package Label-principal Display Panel (1200 mg/60 mg Blister Carton 28 (4 x 7) Unit-dose Tablets)

* Please review the disclaimer below.