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Vanamine PD

Medically reviewed by Drugs.com. Last updated on Nov 1, 2018.

Dosage form: liquid
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 6.25mg in 1mL
Labeler: GM Pharmaceuticals, INC
NDC Code: 58809-643

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.

Vanamine PD

Vanamine PD

NDC 58809-643-30

Antihistamine

1 oz. (30 mL)

Active ingredient (in each mL)

Diphenhydramine HCl 6.25 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
  •  Marked drowsiness may occur
  •  Sedatives and tranquilizers may increase drowsiness

Do Not Use
  •  to make a child drowsy
  • with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if your child has
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if the child is taking

sedatives or tranquilizers.

When using this product
  •  do not use more than directed
  • may cause drowsiness
  • alcohol, sedatives, and tranquilizers may increase drowsiness

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 4 to 6 hours, or as directed by a doctor
  •  do not take more than 6 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 over4 mL (4 dropperfuls)
Children 6 to 12 years of age2 mL (2 dropperfuls)
Children under 6 years of ageAsk a doctor
  • use only with enclosed dropper
  • do not use enclosed dropper for any other drug product

Professional Labeling

Take under guidance of

Health Professionals.

Children 2 to under
6 years of age
1 mL (1 dropperful)
Children under 2 years
of age
Not Recommended

Take every 4 to 6 hours.

Do not exceed 6 doses in 24 hours.

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

Artificial flavor, citric acid anhydrous, FD&C blue #1, glycerin, masking agent, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol solution, sucralose

Questions?

Call 1-888-535-0305

Distributed by:

GM Pharmaceuticals, Inc.

Arlington, TX 76015

Tamper evident by foil seal under cap. Do not use if

PRINCIPAL DISPLAY PANEL

NDC 58809-643-30
Vanamine PD
Each 1 mL contains:
Diphenhydramine HCI 6.25 mg
Antihistamine
1 oz. (30 mL)

VANAMINE PD 
diphenhydramine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58809-643
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE6.25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
TRISODIUM CITRATE DIHYDRATE 
SACCHARIN SODIUM 
ANHYDROUS CITRIC ACID 
FD&C BLUE NO. 1 
GLYCERIN 
SODIUM BENZOATE 
PROPYLENE GLYCOL 
WATER 
SORBITOL 
Packaging
#Item CodePackage Description
1NDC:58809-643-3030 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34104/04/2016
Labeler - GM Pharmaceuticals, INC (793000860)

 
GM Pharmaceuticals, INC

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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