HISTEX- triprolidine hydrochloride syrup

HISTEX by

Drug Labeling and Warnings

HISTEX 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 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

If pregnant or breast-feeding, ask a health professional before use.

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)

INGREDIENTS AND APPEARANCE

HISTEX 
triprolidine hydrochloride syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 28595-802
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM)	TRIPROLIDINE HYDROCHLORIDE	2.5 mg  in 5 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: 28595-802-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/04/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	03/04/2014

Labeler - Allegis Pharmaceuticals, LLC (792272861)