TRIPROLIDINE HYDROCHLORIDE: Package Insert and Label Information

TRIPROLIDINE HYDROCHLORIDE- triprolidine hydrochloride syrup
Westminster Pharmaceuticals, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredient (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 you have

• glaucoma
• a breathing problem such as emphysema or chronic bronchitis
• trouble urinating due to an enlarged prostate gland

Ask a doctor before use if you are taking sedatives or tranquilizers

When using this product

• may cause drowsiness
• excitability may occur, especially in children
• 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 reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

• do not exceed recommended dosage.
• use only the enclosed dropper.
• do not use enclosed dropper for any other drug product.

AGE	DOSE
Adults & Children 12 years of age or older:	2.67 mL (2.5 milligrams) every 4 to 6 hours, not to exceed 10.67 mL (10 milligrams) in 24 hours, or as directed by a doctor.
Children 6 to under 12 years of age:	1.33 mL (1.25 milligrams) every 4 to 6 hours, not to exceed 5.33 mL (5 milligrams) in 24 hours, or as directed by a doctor.
Children under 6 years of age:	consult a doctor.

Other Information

• This packaging is child-resistant.
• Store at room temperature 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, methylparaben, monoammonium glycyrrhizinate, potassium citrate, potassium sorbate, propylene glycol, propylparaben, purified water, sucralose.

Questions? Comments?

Call 1-844-221-7294.

PRINCIPAL DISPLAY PANEL — 30 mL Bottle Carton

NDC 69367-253-30

Triprolidine HCl
Antihistamine
Each dropperful (1 mL) contains:
Triprolidine HCl 0.938 mg

Sugar-Free • Dye Free
Alcohol Free

Tamper evident by foil seal under cap.
Do no use if foil seal is broken or missing.

Bubble Gum Flavor
1 fl oz (30 mL)

Westminster
Pharmaceuticals

TRIPROLIDINE HYDROCHLORIDE triprolidine hydrochloride syrup

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69367-253 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRIPROLIDINE HYDROCHLORIDE (Triprolidine) TRIPROLIDINE HYDROCHLORIDE 0.938 mg in 1 mL

Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE GLYCERIN METHYLPARABEN AMMONIUM GLYCYRRHIZATE POTASSIUM CITRATE POTASSIUM SORBATE PROPYLENE GLYCOL PROPYLPARABEN WATER SUCRALOSE

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

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:69367-253-30 1 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER 1 30 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (69367-253-30)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 03/09/2020

Labeler — Westminster Pharmaceuticals, LLC (079516651)

Revised: 05/2020 Westminster Pharmaceuticals, LLC