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  5. Label Information: Curist Mucus Relief Maximum Strength

FDA Label for Curist Mucus Relief Maximum Strength

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - ACTIVE INGREDIENT
    3. OTC - PURPOSE
    4. INDICATIONS & USAGE
    5. WARNINGS
    6. OTC - DO NOT USE
    7. OTC - ASK DOCTOR
    8. OTC - STOP USE
    9. OTC - PREGNANCY OR BREAST FEEDING
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. DOSAGE & ADMINISTRATION
    12. STORAGE AND HANDLING
    13. INACTIVE INGREDIENT
    14. OTC - QUESTIONS
    15. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Curist Mucus Relief Maximum Strength Product Label

The following document was submitted to the FDA by the labeler of this product Little Pharma, Inc.. 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.

Otc - Active Ingredient



Active ingredient (in each extended-release tablet)

Guaifenesin 1200 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 tablet every 12 hours. Do not exceed 2 tablets in 24 hours.
  • children under 12 years of age: do not use

Storage And Handling



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 Ingredient



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


Otc - Questions



Questions?

Contact 1-877-770-3183

Mon-Fri 8:00 AM EST to 5:00 PM PST.


Package Label.Principal Display Panel



curist

Mucus Relief Maximum Strength

Guaifenesin Extended-Release Tablets 1200 mg

Expectorant

12 Hour

Relieves Chest Congestion

Thins and Loosens Mucus

Immediate and Extended Release

84 (6 x 14) Extended-Release Tablets

Curist-Guaifenesin-1200mg - Curist Guaifenesin 1200mg

Curist-Guaifenesin-1200mg - Curist Guaifenesin 1200mg


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