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  5. Label Information: Guaifenesin

FDA Label for Guaifenesin

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. STOP USE AND ASK A DOCTOR IF
    7. IF PREGNANT OR BREAST-FEEDING,
    8. KEEP OUT OF REACH OF CHILDREN.
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. QUESTIONS?
    13. PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 MG (20 TABLET LABEL)
    14. PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 MG (20 TABLET CARTON LABEL)
    15. PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 MG BLISTER CARTON (14 (1 X 14) TABLETS)

Guaifenesin Product Label

The following document was submitted to the FDA by the labeler of this product Aurohealth Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients



(in each extended-release tablet)

Guaifenesin USP 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 the timing of meals
  • adults and children 12 years of age and over: 1 tablet every 12 hours. Do not exceed 2 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)
  • Tamper evident: Do not use if carton is open or if printed seal on blister is broken or missing

Inactive Ingredients




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


Questions?



1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST) You may also report side effects to this phone number.


Distributed by:
Aurohealth LLC.
2572 Brunswick Pike,
Lawrenceville, NJ 08648

Code: AP/DRUGS/04/2016

Made in India


Package Label-Principal Display Panel - 1200 Mg (20 Tablet Label)



AUROHEALTH

NDC 58602-811-73

MAXIMUM STRENGTH

Guaifenesin
Extended-Release
Tablets 1200 mg
EXPECTORANT

12 HOUR

Package Label-Principal Display Panel - 1200 Mg (20 Tablet Carton Label)



AUROHEALTH

NDC 58602-811-73

Compare to the active
Ingredient in Maximum

Strength Mucinex®*

MAXIMUM STRENGTH

Guaifenesin Extended-Release Tablets 1200 mg
EXPECTORANT

Package Label-Principal Display Panel - 1200 Mg Blister Carton (14 (1 X 14) Tablets)



AUROHEALTH

NDC 58602-811-01

Compare to the active
Ingredient in Maximum

Strength Mucinex®*

MAXIMUM STRENGTH

Guaifenesin
Extended-Release Tablets 1200 mg
EXPECTORANT

* Please review the disclaimer below.