TRIPROLIDINE HYDROCHLORIDE- triprolidine hydrochloride liquid 
Strides Pharma 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

Drug Facts

Active ingredients (in each mL)

Triprolidine HCl USP 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 enclosed dropper
  • do not use enclosed dropper for any other drug product
Adults and children 12 years of age and over
4 mL (2.5 mg)
Children 6 to under 12 years of age
2 mL (1.25 mg)
Children under 6 years of age
ask a doctor

Other Information

  • store at controlled room temperature 15°-30°C (59°-86°F)
  • Tamper Evident: Do not use if seal is broken or missing.

Inactive Ingredients

Bubble Gum Flavor, Citric Acid, Glycerin, Propylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate, Sodium Saccharin, Sorbitol.

Questions?

Call 1-877-244-9825

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

NDC 59556-896-59

Triprolidine Hydrochloride Oral Solution USP

Each 1 mL contains:

Triprolidine HCl USP….. 0.625 mg

Antihistamine

1 oz. (30 mL)

Bubble Gum Flavor

Tamper Evident: Do not use If seal is broken or missing.

Strides Pharma Inc.

Image

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

NDC 59556-896-89

Triprolidine Hydrochloride Oral Solution USP

Each 1 mL contains:

Triprolidine HCl USP….. 0.625 mg

Antihistamine

50 mL

Bubble Gum Flavor

Tamper Evident: Do not use If seal is broken or missing.

Strides Pharma Inc.

Image
TRIPROLIDINE HYDROCHLORIDE 
triprolidine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59556-896
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)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59556-896-591 in 1 CARTON05/21/201905/22/2019
130 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:59556-896-891 in 1 CARTON05/21/201905/22/2019
250 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/21/201905/22/2019
Labeler - Strides Pharma Inc (078868278)
Establishment
NameAddressID/FEIBusiness Operations
Strides Pharma Science Limited918513263ANALYSIS(59556-896) , MANUFACTURE(59556-896) , PACK(59556-896)

Revised: 7/2020
 
Strides Pharma Inc