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  5. Label Information: Kids-eeze Chest Relief

FDA Label for Kids-eeze Chest Relief

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH SOFT CHEW)
    2. PURPOSE
    3. USES
    4. OTC - ASK DOCTOR
    5. OTC - STOP USE
    6. OTC - PREGNANCY OR BREAST FEEDING
    7. OTC - KEEP OUT OF REACH OF CHILDREN
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENTS
    11. OTC - QUESTIONS
    12. PRINCIPAL DISPLAY PANEL - 100 MG TABLET CARTON

Kids-eeze Chest Relief Product Label

The following document was submitted to the FDA by the labeler of this product Prophase Labs, 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.

Active Ingredient (In Each Soft Chew)



Guaifenesin, USP 100 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.


Otc - Ask Doctor



Ask a doctor before use if you have

  • a sodium-restricted diet
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough that occurs with 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 condition.


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.


Directions



Chew and swallow as directed below

  • Do not take more than 6 doses in 24 hours
    • adults and children 12 years and over2 to 4 chews every 4 hours
    children 6 years to under 12 years1 to 2 chews every 4 hours
    children under 6 years of ageask a doctor

Other Information



  • each soft chew contains 17 mg sodium
  • tamper evident: do not use if inner blister pack is torn or open
  • store at controlled room temperature 20-25°C (68-77°F)

Inactive Ingredients



croscarmelose sodium, ethylcellulose, FD&C red #40 lake, ethylene glycol & vinyl alcohol graft copolymer, malic acid, methacrylic copolymer, monoammonium glycyrrhizinate, non fat dry milk, octaglycerol monooleate emulsifier, vegetable oil, polysorbate 80, salt, silicon dioxide, sodium starch glycolate, soy lecithin, strawberry flavors, sucralose, sugar, vanilla flavor


Otc - Questions



To report serious side effects associated with the use of this product call 1-800-505-COLD (2653)


Principal Display Panel - 100 Mg Tablet Carton



NDC 61941-1002-6

Kids-EEZE®

From The Makers Of
Cold-EEZE®

Chest
Relief

EXPECTORANT • GUAIFENESIN 100 mg

* Please review the disclaimer below.