VANAMINE PD- diphenhydramine hydrochloride liquid

Vanamine PD by

Drug Labeling and Warnings

Vanamine PD 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

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 over: 4 mL (4 dropperfuls)
• Children 6 to 12 years of age: 2 mL (2 dropperfuls)
• Children under 6 years of age: Ask 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

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

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

VANAMINE PD 
diphenhydramine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58809-643
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	6.25 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BENZOATE (UNII: OJ245FE5EU)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58809-643-30	30 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)