Indications and 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
HISTEX™ Syrup
- Manufacturer
- Allegis Pharmaceuticals, LLC
- Effective date
- 2024-01-08
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 00:06:55
Label at a glance#
ProductHISTEX
Active ingredientTRIPROLIDINE HYDROCHLORIDE
Label structure10 sections
Dosage and administration
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
Storage and handling
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.
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
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 SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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)
DailyMed RxNorm Mappings#
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 30c51294-7ae9-8007-7de6-58222684a0be | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 28595-802-08 | HISTEX | 237 mL in 1 BOTTLE | SYRUP | 237 | 4 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 28595-802-08 | ML - Milliliter | 28595-802 | 3510fcc6-5786-45f1-9743-4135e56e4125 | 1 | 2014-05-02 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| TRIPROLIDINE HYDROCHLORIDE | ACTIVE INGREDIENT | YAN7R5L890 | 1 | |
| TRIPROLIDINE | ACTIVE MOIETY | 2L8T9S52QM | 1 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | 1 | |
| SODIUM CITRATE | INACTIVE INGREDIENT | 1Q73Q2JULR | 1 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
Every source-derived product name is available through these pages.
- HISTEX
- TRIPROLIDINE HYDROCHLORIDE
- SODIUM BENZOATE
- CITRIC ACID MONOHYDRATE
- GLYCERIN
- PROPYLENE GLYCOL
- WATER
- SODIUM CITRATE, UNSPECIFIED FORM
- SACCHARIN SODIUM
- SORBITOL
- TRIPROLIDINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 28595-802 | 28595-802-08 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM CITRATE, UNSPECIFIED FORM | 1Q73Q2JULR | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| SORBITOL | 506T60A25R | IACT |
| TRIPROLIDINE HYDROCHLORIDE | YAN7R5L890 | ACTIB |
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SYRUP / ORAL | 722 mg/5ml | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SYRUP / ORAL | 5700 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SYRUP / ORAL | 4370 mg/5ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SYRUP / ORAL | 16734 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | SYRUP / ORAL | 24 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SYRUP / ORAL | 5700 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SYRUP / ORAL | 16734 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SYRUP / ORAL | 4370 mg/5ml | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SYRUP / ORAL | 722 mg/5ml | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | SYRUP / ORAL | 24 mg |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| HISTEX | TRIPROLIDINE HYDROCHLORIDE | Allegis Pharmaceuticals, LLC | cc466d33-cf3e-4f1c-a794-6d3d79903adf | 2024-01-08 | Warnings | 28595-802-08 28595-802 28595080208 0e764061-e7a9-6701-e063-6394a90a489f cc466d33-cf3e-4f1c-a794-6d3d79903adf |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.