Label: TRIPROLIDINE HCL DROPS liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 Label Information

Updated November 2, 2021

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  • 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

    label

  • INGREDIENTS AND APPEARANCE
    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)
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