VANAMINE PD- diphenhydramine 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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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 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)

VANAMINE PD
diphenhydramine hydrochloride liquid

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58809-643-30	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/04/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	04/04/2016	12/30/2020

Labeler - GM Pharmaceuticals, INC (793000860)

Revised: 1/2021

Document Id: b971b647-2ccc-4e24-e053-2995a90a9246

Set id: 31561793-6d6c-2abe-e054-00144ff8d46c

Version: 4

Effective Time: 20210121

GM Pharmaceuticals, INC