FDA.reportPublic FDA data

Vanamine PD

Manufacturer
GM Pharmaceuticals, INC
Effective date
2019-11-25
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:57:56

Label at a glance#

ProductVanamine PD
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections

Indications and 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

Dosage and administration

 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 ...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Vanamine PD
NDC 58809-643-30
Antihistamine
1 oz. (30 mL)

Active ingredient (in each mL)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 6.25 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

  •  may cause excitability, especially in children
  •  marked drowsiness may occur
  •  sedatives and tranquilizers may increase drowsiness

Do Not Use

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use

OTC - ASK DOCTOR/PHARMACIST SECTION

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:

OTC - STOP USE SECTION

  • nervousness, dizziness or sleeplessness occurs
  • symptoms do not improve within 7 days or are accompanied by a fever

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  •  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

Other Information

OTHER SAFETY 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

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

Call 1-888-535-0305

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

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58809-643-30ML - Milliliter58809-6435045d7b0-9be1-4179-93f4-db3415cdf12a12016-11-08

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58809-64358809-643-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
GLYCERINPDC6A3C0OXIACT
SODIUM BENZOATEOJ245FE5EUIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b971b647-2ccc-4e24-e053-2995a90a924631561793-6d6c-2abe-e054-00144ff8d46c2021-01-21WarningsExact identifier
spl set id: 31561793-6d6c-2abe-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.