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  5. Label Information: Triprolidine Hydrochloride

FDA Label for Triprolidine Hydrochloride

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH 1 ML DROPPERFUL)
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. ASK A DOCTOR BEFORE USE IF THE CHILD HAS
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR IF
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS? COMMENTS?
    14. PRINCIPAL DISPLAY PANEL - 30 ML BOTTLE LABEL

Triprolidine Hydrochloride Product Label

The following document was submitted to the FDA by the labeler of this product Westminster 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 0.938 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

Warnings



Do not exceed recommended dosage.


Ask A Doctor Before Use If The Child Has



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

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


When Using This Product



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

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.
    • AGEDOSE
    Adults & Children 12 years of age or older:2.67 mL (2.5 milligrams) every 4 to 6 hours, not to exceed 10.67 mL (10 milligrams in 24 hours, or as directed by a doctor.
    Children 6 to under 12 years of age:1.33 mL (1.25 milligrams) every 4 to 6 hours, not to exceed 5.33 mL (5 milligrams in 24 hours, or as directed by a doctor.
    Children under 6 years of age:Consult 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 1-844-221-7294.


Principal Display Panel - 30 Ml Bottle Label



NDC 69367-253-30

Triprolidine HCl
Antihistamine
Each dropperful (1 mL) contains:
Triprolidine HCl    0.938 mg
Sugar-Free • Dye Free
Alcohol Free

Bubble Gum Flavor
1 fl oz (30 mL)

Westminster
Pharmaceuticals

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label - triprolidine 01

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label - triprolidine 01


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