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  5. Label Information: On The Go-dose

FDA Label for On The Go-dose

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (PER 5 ML = ONE PRE-FILLED VIAL)
    2. PURPOSE
    3. USES
    4. DO NOT USE
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU
    7. WHEN USING THIS PRODUCT
    8. CHOKING HAZARD: SMALL PARTS. KEEP OUT OF REACH OF CHILDREN.
    9. IF PREGNANT OR BREAST-FEEDING,
    10. KEEP OUT OF REACH OF CHILDREN.
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS OR COMMENTS?
    15. ON THE GO-DOSE DIPHENHYDRAMINE HCL ANTI-HISTAMINE ORAL SOLUTION 12.5MG (58292-011-05)

On The Go-dose Product Label

The following document was submitted to the FDA by the labeler of this product Perfect Measure 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 (Per 5 Ml = One Pre-Filled Vial)



Diphenhydramine HCl 12.5 mg


Purpose



Antihistamine


Uses



For the temporary relief of these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes

Do Not Use



  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin

Ask A Doctor Before Use If You Have



  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland
  • a sodium-restricted diet
  • a breathing problem such as emphysema or chronic bronchitis

Ask A Doctor Or Pharmacist Before Use If You



are taking sedatives or tranquilizers


When Using This Product



marked drowsiness may occur

avoid alcoholic beverages

alcohol, sedatives, and tranquilizers may increase the drowsiness effect

use caution when driving a motor vehicle or operating machinery

excitability may occur, especially in children


Choking Hazard: Small Parts. Keep Out Of Reach Of Children.




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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.


Directions



Adults and children 12 years of age and over

Take 2-4 pre-filled vial every 4 to 6 hours, not to exceed 24 whistles in 24 hours, or as directed by a doctor

Children 6 to under 12 years of age

Take 1-2 pre-filled vial every 4 to 6 hours, not to exceed 12 whistles in 24 hours, or as directed by a doctor

Children under 6 years of age

Consult a doctor


Other Information



  • Each pre-filled vial contains 14 mg of sodium
  • Protect from light.
  • SAFETY SEALED: This product is protected by a sealed pouch. Do not use if individual foil pouch is torn or damaged.
  • Whistle is not child resistant. Do not remove whistle from child resistant foil pouch prior to use.
  • Store between 68 degrees-77 degrees F (20 degrees - 25 degrees C)
  • Store in outer carton until contents are used.

Inactive Ingredients



anhydrous citric acid, DandC red no. 33, FDandC red no.40, flavor, glycerin, monoammonium glycyrrhizinate, poloxamer 407, sodium benzoate, sodium chloride, sodium citrate, sucrose, water


Questions Or Comments?



1-855-251-0106


On The Go-Dose Diphenhydramine Hcl Anti-Histamine Oral Solution 12.5Mg (58292-011-05)



Outer Label - OuterLabel

Outer Label - OuterLabel


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