VANAHIST PD description, usages, side effects, indications, overdosage, supplying and lots more!

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VANAHIST PD

GM PHARMACEUTICALS,INC

VANAHIST™ PD


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredients (in each mL)

Triprolidine HCl 0.625 mg

Purpose

Antihistamine

VANAHIST PD 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 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

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

Professional Labeling

Take under guidance of Health Professionals.

Children 4 months to under 2 years of age 0.5 mL (0.313 mg)

VANAHIST PD

Children 2 to under 4 years of age 1 mL (0.626 mg)
Children 4 to under 6 years of age 1.5 mL (0.938 mg)

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

Questions?

Call 1-888-535-0305

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

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label

NDC 58809-501-30

VANAHIST™ PD

Each 1 mL contains:
Triprolidine HCl
0.625 mg

Antihistamine

Strawberry-banana Flavor

1 oz. (30 mL)

GMPharmaceuticals, Inc.

VANAHIST PD

VANAHIST PD

TRIPROLIDINE HYDROCHLORIDE LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:58809-501
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
triprolidine hydrochloride TRIPROLIDINE 0.625 mg

Inactive Ingredients

Ingredient Name Strength
CITRIC ACID MONOHYDRATE
FD&C RED NO. 40
GLYCERIN
AMMONIUM GLYCYRRHIZATE
METHYLPARABEN
POTASSIUM CITRATE
POTASSIUM SORBATE
PROPYLPARABEN
propylene glycol
water
Strawberry
Sucralose

Product Characteristics

Color
RED

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 30 in 1 BOTTLE, DROPPER
2 NDC:58809-501-30 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2014-03-19


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Be sure to consult your doctor before taking any medication!
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