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Drug Facts
Histex Pd Drops New Formulation Syrup
FDA Label NDC 28595-809
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 Pd Drops New Formulation (NDC 28595-809). 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 other, active ingredient (in each 1 ml dropperful), purpose, uses, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
- use only the enclosed dropper.
- do not use enclosed dropper for any other drug products.
| AGE | DOSE |
|---|---|
| Adutls & Children 12 years of age or older: | 2 mL (2.5 mg) every 4 to 6 hours, not to exceed 8 mL (10 mg) in 24 hours or as directed by a doctor. |
| Children 6 to under12 years of age: | 1 mL (1.25 mg) every 4 to 6 hours, not to exceed 4 mL (5 mg) in 24 hours or as directed by a doctor. |
| Children under 6 years of age: | Consult a docotor. |
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, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose.
Questions? Comments?
Call 1-866-633-9033.
Principal Display Panel - 30 Ml Bottle Carton
NDC 28595-809-30
HISTEX™ PD New Formulation
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) Bottle
* Please review the disclaimer below.
