VANACLEAR PD- triprolidine hydrochloride liquid 
GM Pharmaceuticals, 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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Vanaclear PD

VanaClear PD
NDC 58809-485-50
Antihistamine
50 mL 

Active ingredients (in each mL)

Triprolidine HCl  0.313 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
Adults and children 12 years of age and over8 mL (8 dropperfuls)
Children 6 to 12 years of age4 mL (4 dropperfuls)
Children under 6 years of ageAsk a doctor

  • use only with enclosed dropper
  • do not use enclosed dropper for any other drug product

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

Citric acid anhydrous, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sodium saccharin, sorbitol 

Questions?

Call 1-888-535-0305


Distributed by:
GM Pharmaceuticals, Inc.
Arlington, TX 76015

PRINCIPAL DISPLAY PANEL

NDC 58809-485-50
VanaClear PD
Each 1 mL contains:
Triprolidine HCI…….0.313 mg
Antihistamine
(50 mL)

NDC 58809-485-50 VanaClear PD Each 1 mL contains: Triprolidine HCI…….0.313 mg Antihistamine (50 mL)

VANACLEAR  PD
triprolidine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58809-485
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM) TRIPROLIDINE HYDROCHLORIDE0.313 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GLYCERIN (UNII: PDC6A3C0OX)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58809-485-5050 mL in 1 BOTTLE; Type 0: Not a Combination Product04/04/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/04/201612/30/2020
Labeler - GM Pharmaceuticals, INC (793000860)

Revised: 1/2021
Document Id: b8f3834b-2376-6f4c-e053-2a95a90aa33c
Set id: 316b6302-f9ac-73fd-e054-00144ff88e88
Version: 5
Effective Time: 20210115
 
GM Pharmaceuticals, INC