TRIPROLIDINE HCL DROPS- triprolidine hcl drops liquid 
Creekwood Pharmaceutical Inc.

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.

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Triprolidine HCL Drops

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.

Uses

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

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

label

TRIPROLIDINE HCL DROPS 
triprolidine hcl drops liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15310-112
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM) TRIPROLIDINE HYDROCHLORIDE0.938 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorCOTTON CANDYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:15310-112-421 in 1 BOX12/06/2019
130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/06/2019
Labeler - Creekwood Pharmaceutical Inc. (618997188)
Establishment
NameAddressID/FEIBusiness Operations
Woodfield Pharmaceutical, LLC079398730manufacture(15310-112)

Revised: 11/2021
Document Id: cfd44096-36a6-624a-e053-2995a90af1fa
Set id: 990c6ee8-69e1-6f35-e053-2a95a90a0601
Version: 2
Effective Time: 20211102
 
Creekwood Pharmaceutical Inc.