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  5. Label Information: Histex

FDA Label for Histex

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH 5 ML TEASPOONFUL)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. WHEN USING THIS PRODUCT
    7. STOP USE AND ASK A DOCTOR IF
    8. OTC - PREGNANCY OR BREAST FEEDING
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS? COMMENTS?
    14. PRINCIPAL DISPLAY PANEL - 237 ML BOTTLE LABEL

Histex 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.

Active Ingredients (In Each 5 Ml Teaspoonful)



Triprolidine HCl 2.5 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 You Have



  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland

    • Ask a doctor before use if you are taking sedatives or tranquilizers


When Using This Product



  • excitability may occur, especially in children
  • may cause drowsiness
  • alcohol, sedatives and tranquilizers may increase the drowsiness effect
  • avoid alcoholic beverages
  • use caution when driving a motor vehicle or operating machinery

Stop Use And Ask A Doctor If



  • new symptoms occur

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 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.

AGEDOSE
Adults and Childen 12 years of age and older:1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 4 teaspoonfuls (20 mL) in 24 hours, or as directed by a doctor
Childen 6 to under 12 years of age½ teaspoonful (2.5 mL) every 4 to 6 hours, not to exceed 2 teaspoonfuls (10 mL) in 24 hours, or as directed by a doctor.
Children under 6 years of ageConsult 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.

Dispense in a tight, light-resistant container with a child-resistant cap.


Inactive Ingredients



Citric Acid, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol, Bubble Gum Flavor.


Questions? Comments?



Call 1-866-633-9033.


Principal Display Panel - 237 Ml Bottle Label



NDC 28595-802-08

Antihistamine

HISTEX™
Syrup

Each teaspoonful (5 mL)
contains:
Triprolidine HCl    2.5 mg

Sugar-Free • Dye Free
Alcohol Free

Bubble Gum Flavor

8 fl oz (237 mL)

Principal Display Panel - 237 mL Bottle Label - histex 01

Principal Display Panel - 237 mL Bottle Label - histex 01


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