TRIPROLIDINE HCL DROPS liquid

Triprolidine HCl Drops by

Drug Labeling and Warnings

Triprolidine HCl Drops by is a Otc medication manufactured, distributed, or labeled by Creekwood Pharmaceutical Inc., Woodfield Pharmaceutical, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Other information

Store at 59° - 86°F (15° - 30°C)

Warnings

Do not exceed recommended dosage.

Ask a doctor before use if the child has

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• diffculty in urination due to the enlargement of the prostate gland
• a breathing problem such as emphysema or chronic bronchitis
• glaucoma
  

Do not use this product

• in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
  

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur
• symptoms do not improve within 7 days or are accompanies by fever

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Uses

Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

• Nasal Congestion
• reduces swelling of nasal passages
• runny nose
• sneezing
• itching of the nose or throat
• itchy,watery eyes

Drug Facts

Active ingredients

(in each 1 mL dropperful)

Triprolidine Hydrochloride 0.938mg

Purpose

Anitihistamine

Directions

Do Not exceed recommended dosage.

Use only with enclosed dropper. Do not use with any other device.

• Adults and Children 12 years of age and over: 2.67 mL every 4 hours to 6 hours,not to exceed 4 doses in 24 ; hours
• Children 6 years to under 12 years of age: 1.33mL every 4 to 6 hours, not to exceed 4 doses in 24 hours
• Children under 6 years of age: Consult a doctor.

Inactive ingredients

Citric Acid, Cotton Candy Flavor, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol, Sucralose.

Questions Comments

Seek medical assistance immediately for serious side effects associated with the use of this product. Serious side effects may be reported to this number: 866-991-9870 ( mon-Fri 8 a.m to 5 p.m EST)

Product Packaging

The packaging below represents the labeling currently used.



Principal display panel and side panel for 30 mL label:



NDC: 15310-112-42

Triprolidine HCl Drops

Alllergic Rhintis, Respiratory Allergies & Nasal Decongestant

Common Cold

Alcohol-Free · Dye Free · Sugar Free · · Cotton Candy Flavor



Each Dropperful (1 mL) contains:

Triprolidine HCl, USP..........................0.938 mg





Net Wt. 1 FL OZ (30 mL)



Tamper evident by foil seal under cap.

Do not use if foil seal is broken or missing.

Manufactured for:

Creekwood Pharmaceutical

951 Clint Moore Road,

Suite A

Boca Taton, FL 33487

INGREDIENTS AND APPEARANCE

TRIPROLIDINE HCL DROPS 
triprolidine hcl drops liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 15310-112
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color		Score
Shape		Size
Flavor	COTTON CANDY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 15310-112-42	1 in 1 BOX	12/06/2019
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	12/06/2019

Labeler - Creekwood Pharmaceutical Inc. (618997188)

Establishment
Name	Address	ID/FEI	Business Operations
Woodfield Pharmaceutical, LLC		079398730	manufacture(15310-112)