Active Ingredients (In Each 5 Ml Teaspoonful)
Triprolidine HCl 2.5 mg
Histex Syrup
FDA Label NDC 28595-802
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Allegis Pharmaceuticals, Llc for the product Histex (NDC 28595-802). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients (in each 5 ml teaspoonful), purpose, uses, warnings, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
| AGE | DOSE |
|---|---|
| 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 age | ½ 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 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.
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)
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