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  5. Label Information: Topcare Mucus Er

FDA Label for Topcare Mucus Er

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH EXTENDED-RELEASE TABLET)
    2. PURPOSE
    3. USES
    4. DO NOT USE
    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 OR COMMENTS?
    13. PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Topcare Mucus Er Product Label

The following document was submitted to the FDA by the labeler of this product Topco Associates 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 Ingredient (In Each Extended-Release Tablet)



Guaifenesin 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

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 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°-25°C (68°-77°F)

Inactive Ingredients



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


Questions Or Comments?



1-888-423-0139


Package/Label Principal Display Panel



TopCare® health

COMPARE TO MAXIMUM STRENGTH MUCINEX® ACTIVE INGREDIENT

MAXIMUM STRENGTH

Mucus ER

GUAIFENESIN EXTENDED-RELEASE TABLETS, 1200 mg

EXPECTORANT

12 HOUR

• Relieves Chest Congestion

• Thins and Loosens Mucus

• Immediate and Extended Release

28 EXTENDED-RELEASE TABLETS

actual size

Mucus ER Carton - image 01

Mucus ER Carton - image 01


* Please review the disclaimer below.