TRIPROLIDINE HYDROCHLORIDE- triprolidine hydrochloride liquid 
Woodward Pharma Services 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.

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Triprolidine Hydrochloride

Drug Facts

Active ingredients (in each mL)

Triprolidine HCl 0.625 mg

Purpose

Antihistamine

Uses

  • Temporarily relieves:
    • runny nose
    • sneezing
    • itching of nose and throat
    • itchy, watery eyes due to hay fever or other upper respiratory allergies or allergic rhinitis

Warnings

  • may cause excitability, especially in children

Do Not Use

  • if you or your children are taking sedatives or tranquilizers, without first consulting your doctor
  • with any other product containing triprolidine

Ask a doctor before use if your child has

  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urination due to enlargement of the prostate gland

When using this product

  • do not use more than directed
  • may cause drowsiness
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

  • nervousness, dizziness or sleeplessness occurs
  • symptoms do not improve within 7 days or are accompanied by a fever

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.

Directions

  • take every 6 hours
  • do not take more than 4 doses in 24 hours or as directed by a doctor
  • do not give more than directed or exceed the recommended daily dosage
  • use only with enclosed oral syringe
  • do not use enclosed oral syringe for any other drug product
Adults and children 12 years of age and over4 mL (2.5 mg)
Children 6 to under 12 years of age2 mL (1.25 mg)
Children under 6 years of ageask a doctor

Other Information

  • store at controlled room temperature 20°-25°C (68°-77°F)
  • Tamper Evident: Do not use if seal is broken or missing.

Inactive ingredients

Banana flavor, citric acid, FD&C red #40, glycerin, magnasweet, methylparaben, potassium citrate, potassium sorbate, propylparaben, propylene glycol, purified water, strawberry flavor and sucralose

Questions or Comments

Please Call 1-888-514-4727

Distributed by:
Woodward Pharma Services LLC
Birmingham, MI 48009

Professional Labeling

Take under guidance of Health Professionals.

Children 4 months to under 2 years of age0.5 mL (0.313 mg)
Children 2 to under 4 years of age1 mL (0.625 mg)
Children 4 to under 6 years of age1.5 mL (0.938 mg)

Take every 6 hours. Do not exceed 4 doses in 24 hours.

Dropper image

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label

NDC 69784-102-01

Triprolidine Hydrochloride Oral Solution

Each 1 mL contains:
Triprolidine HCl
0.625 mg

Antihistamine

1 oz. (30 mL)

Strawberry-banana Flavor

Tamper Evident: Do not use if imprinted cap seal is broken or missing

WOODWARD PHARMA

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label
TRIPROLIDINE HYDROCHLORIDE 
triprolidine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69784-102
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM) TRIPROLIDINE HYDROCHLORIDE0.625 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POTASSIUM CITRATE (UNII: EE90ONI6FF)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorREDScore    
ShapeSize
FlavorBANANA, STRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69784-102-011 in 1 CARTON10/10/201603/15/2020
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 FINALpart34110/10/201603/15/2020
Labeler - Woodward Pharma Services LLC (026749066)

Revised: 6/2020
Document Id: bee5cde2-9763-41ba-a061-9bf8216c1487
Set id: 5c2fb4cc-c5a3-421c-91d4-c5bbe2189467
Version: 4
Effective Time: 20200601
 
Woodward Pharma Services LLC