FDA.reportPublic FDA data

On The GO-Dose Diphenhydramine HCL Anti-Histamine Oral Solution

Manufacturer
Perfect Measure LLC | Horizon Pharmaceuticals, Inc.
Effective date
2017-01-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:48:40

Label at a glance#

ProductOn The GO-Dose
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

For the temporary relief of these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itching of the nose or throat itchy, watery eyes

Dosage and administration

Adults and children 12 years of age and over Take 2-4 pre-filled vial every 4 to 6 hours, not to exceed 24 whistles in 24 hours, or as directed by a doctor Children 6 to under 12 years of age Take 1-2 pre-filled vial every 4 to 6 hours, not to exceed 12 whistles in 24 hours, or as directed by a doctor Children under 6 years of age Consult a doctor

Storage and handling

Each pre-filled vial contains 14 mg of sodium Protect from light. SAFETY SEALED: This product is protected by a sealed pouch. Do not use if individual foil pouch is torn or damaged. Whistle is not child resistant. Do not remove whistle from child resistant foil pouch prior to use. Store between 68 degrees-77 degrees F (20 degrees - 25 degrees C) Store in outer carton until contents are used.

Label contents#

Full prescribing information#

Active ingredient (per 5 ml = one pre-filled vial)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 12.5 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland
  • a sodium-restricted diet
  • a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you

OTC - ASK DOCTOR/PHARMACIST SECTION

are taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

marked drowsiness may occur

avoid alcoholic beverages

alcohol, sedatives, and tranquilizers may increase the drowsiness effect

use caution when driving a motor vehicle or operating machinery

excitability may occur, especially in children

Choking Hazard: Small parts. Keep out of reach of children.

PRECAUTIONS SECTION

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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and over

Take 2-4 pre-filled vial every 4 to 6 hours, not to exceed 24 whistles in 24 hours, or as directed by a doctor

Children 6 to under 12 years of age

Take 1-2 pre-filled vial every 4 to 6 hours, not to exceed 12 whistles in 24 hours, or as directed by a doctor

Children under 6 years of age

Consult a doctor

Other information

STORAGE AND HANDLING SECTION

  • Each pre-filled vial contains 14 mg of sodium
  • Protect from light.
  • SAFETY SEALED: This product is protected by a sealed pouch. Do not use if individual foil pouch is torn or damaged.
  • Whistle is not child resistant. Do not remove whistle from child resistant foil pouch prior to use.
  • Store between 68 degrees-77 degrees F (20 degrees - 25 degrees C)
  • Store in outer carton until contents are used.

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, DandC red no. 33, FDandC red no.40, flavor, glycerin, monoammonium glycyrrhizinate, poloxamer 407, sodium benzoate, sodium chloride, sodium citrate, sucrose, water

Questions or comments?

OTC - QUESTIONS SECTION

1-855-251-0106

On The GO-Dose Diphenhydramine HCL Anti-Histamine Oral Solution 12.5mg (58292-011-05)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer LabelOuter Label

Inner LabelInner Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN1
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD1
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY1
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY1
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58292-011-052020-01-31C16284748780-19d75b9d0-195d-f424-e053-dadaa90a57ceOn The GO-Dose Diphenhydramine HCL Anti-Histamine Oral Solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58292-011-05On The GO-Dose5 mL in 1 VIALSOLUTION51
58292-011-05On The GO-Dose10 in 1 PACKAGESOLUTION101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58292-011ON THE GO-DOSE (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [PERFECT MEASURE LLC]1Legacy NDC, 2 package rows20170201_3152f596-327a-4f49-9f26-70e2006956bb.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58292-01158292-011-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
D&C RED NO. 339DBA0SBB0LIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
AMMONIUM GLYCYRRHIZATE3VRD35U26CIACT
POLOXAMER 407TUF2IVW3M2IACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM CITRATE1Q73Q2JULRIACT
SUCROSEC151H8M554IACT
WATER059QF0KO0RIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB

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
476632b8-7a0a-742a-e054-00144ff88e883152f596-327a-4f49-9f26-70e2006956bb2017-01-31WarningsExact identifier
spl id: 476632b8-7a0a-742a-e054-00144ff88e88
spl set id: 3152f596-327a-4f49-9f26-70e2006956bb

Reported adverse events (FAERS/openFDA)#

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