VANACLEAR PD- triprolidine hydrochloride liquid

VanaClear by

Drug Labeling and Warnings

VanaClear by is a Otc medication manufactured, distributed, or labeled by GM Pharmaceuticals, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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 over: 8 mL (8 dropperfuls)
• Children 6 to 12 years of age: 4 mL (4 dropperfuls)
• 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

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)

INGREDIENTS AND APPEARANCE

VANACLEAR  PD
triprolidine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58809-485
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM)	TRIPROLIDINE HYDROCHLORIDE	0.313 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58809-485-50	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/04/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	04/04/2016

Labeler - GM Pharmaceuticals, INC (793000860)