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  5. Label Information: Leader Nausea Relief

FDA Label for Leader Nausea Relief

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (PER 5 ML)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. STOP USE AND ASK A DOCTOR IF
    8. IF PREGNANT OR BREAST-FEEDING,
    9. KEEP OUT OF REACH OF CHILDREN.
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS OR COMMENTS?
    14. PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Leader Nausea Relief Product Label

The following document was submitted to the FDA by the labeler of this product Cardinal Health 110, Llc. Dba Leader. 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 (Per 5 Ml)



Dextrose (glucose) 1.87g

Levulose (fructose) 1.87g

Phosphoric acid 21.5mg


Purpose



Upset stomach reliever


Uses



  • •for relief of upset stomach associated with nausea

Warnings



  • •this product contains fructose and should not be taken by persons with hereditary fructose intolerance (HFI)

Do Not Use



if you have

  • •allergic reactions to any of the ingredients in this product

Ask A Doctor Before Use If You Have



  • •diabetes

Stop Use And Ask A Doctor If



  • •symptoms persist, return or get worse

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



  • •for maximum effectiveness, never dilute or drink fluids of any kind immediately before or after taking this product
  • •repeat dose every 15 minutes or until distress subsides
  • •do not take more than 5 doses in 1 hour without consulting a doctor
  • •measure only with dosing cup provided. Dosing cup to be used with this product only. Do not use with other products.
  • •mL = milliliters

    • age

    dose

    adults and children 12 years of age and over

    15 mL or 30 mL

    children 2 to under 12 years of age

    5 mL or 10 mL


Other Information



  • •store at 20-25°C (68-77°F) away from heat and direct light; keep from freezing.
  • •do not use if printed neckband is broken or missing

Inactive Ingredients



FD&C red no. 40 aluminum lake, flavor, glycerin, methylparaben, purified water


Questions Or Comments?



1-800-719-9260


Package/Label Principal Display Panel



Children | Adult

Nausea Relief

Dextrose (Glucose)

Levulose (Fructose)

Phosphoric Acid

Nausea & Upset Stomach

Cherry Flavor

Antihistamine-Free

Aspirin-Free

Alcohol-Free

Caffeine-Free

COMPARE TO EMETROL® active ingredients

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4 FL OZ (118 mL)

291-e9-nausea-relief.jpg - 291 e9 nausea relief

291-e9-nausea-relief.jpg - 291 e9 nausea relief


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