HISTEX PD DROPS- triprolidine hydrochloride syrup

HISTEX PD Drops by

Drug Labeling and Warnings

HISTEX PD Drops by is a Otc medication manufactured, distributed, or labeled by Allegis Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (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

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
Childen 4 to under 6 years of age:	1 dropperful (1.0 mL) every 4 to 6 hours, not to exceed 4 doses (4.0 mL) in 24 hours
Children 2 to under 4 years of age	⅔ dropperful (0.67 mL) every 4 to 6 hours, not to exceed 4 doses (2.67 mL) in 24 hours
Infants 4 months to under 2 years of age	⅓ dropperful (0.33 mL) every 4 to 6 hours, not to exceed 4 doses (1.33 mL) in 24 hours

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 - 30 mL Bottle Label

NDC: 28595-801-30

Histex™ PD
Drops

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)

INGREDIENTS AND APPEARANCE

HISTEX PD DROPS 
triprolidine hydrochloride syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 28595-801
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM)	TRIPROLIDINE HYDROCHLORIDE	0.938 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color		Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 28595-801-30	1 in 1 CARTON	03/06/2014
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	03/06/2014

Labeler - Allegis Pharmaceuticals, LLC (792272861)