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  5. Label Information: Histex Pdx Drops

FDA Label for Histex Pdx Drops

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH 1 ML DROPPERFUL)
    3. PURPOSE
    4. USES
    5. OTC - DO NOT USE
    6. OTC - ASK DOCTOR
    7. OTC - ASK DOCTOR/PHARMACIST
    8. OTC - WHEN USING
    9. OTC - STOP USE
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS? COMMENTS?
    15. PRINCIPAL DISPLAY PANEL - 30 ML BOTTLE CARTON

Histex Pdx Drops Product Label

The following document was submitted to the FDA by the labeler of this product Allegis Pharmaceuticals, 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.

Other



Drug Facts


Active Ingredient (In Each 1 Ml Dropperful)



Triprolidine HCl 1.25 mg


Purpose



Antihistamine


Uses



temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:

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

Otc - Do Not Use



Do not exceed recommended dosage.


Otc - Ask Doctor



Ask a doctor before use if the child has

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma

Otc - Ask Doctor/Pharmacist



Ask a doctor before use if the child is taking sedatives or tranquilizers


Otc - When Using



When using this product

  • excitability may occur, especially in children
  • may cause drowsiness
  • sedatives and tranquilizers may increase the drowsiness effect

Otc - Stop Use



Stop use and ask a doctor if

  • new symptoms occur

Otc - Keep Out Of Reach Of Children



Keep out of the reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.


Directions



Do not exceed recommended dosage.

  • For dosing, use only the enclosed dropper and not with any other drug product.
  • Professional Labeling: Take under the guidance of Health Professionals.
    • AGEDOSE
    Children 4 to under 6 years of age:¾ dropperful (0.75 mL) every 4 to 6 hours, not to exceed 4 doses (3.0 mL) in 24 hours or as directed by a Doctor.
    Children 2 to under 4 years of age:½ dropperful (0.5 mL) every 4 to 6 hours, not to exceed 4 doses (2.0 mL) in 24 hours or as directed by a Doctor.
    Infants 4 months to under 2 years of age:¼ dropperful (0.25 mL) every 4 to 6 hours, not to exceed 4 doses (1.0 mL) in 24 hours or as directed by a Doctor.

Other Information



Store at 15°-30° C (59°-86° F).

Tamper evident by foil seal under cap. Do not use if foil seal is missing or broken.


Inactive Ingredients



bubble gum flavor, citric acid, glycerin, methylparaben, monoammonium glycyrrhizinate, potassium citrate, potassium sorbate, propylene glycol, propylparaben, purified water, sucralose.


Questions? Comments?



Call 1-866-633-9033.


Principal Display Panel - 30 Ml Bottle Carton



NDC 28595-808-30

HISTEX™ PDX
Drops

Antihistamine

Each dropperful (1 mL)
contains:
Triprolidine HCl
1.25 mg

Sugar-Free • Dye Free
Alcohol Free

Bubble Gum Flavor

1 fl oz (30 mL)


* Please review the disclaimer below.