First Aid Shot Therapy Allergy Relief

Manufacturer
First Aid Beverages, Inc.
Effective date
2016-06-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:46:28

Label at a glance#

ProductFirst Aid Shot Therapy Allergy Relief
Active ingredientDiphenhydramine Hydrochloride
Label structure11 sections

Indications and uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose and throat temporarily relieves these symptoms due to the common cold: runny nose sneezing

Dosage and administration

Adults and children 12 years and over: swallow the contents of one bottle repeat every 4-6 hours while symptoms persist, or as directed by doctor do not take more than 6 bottles in 24 hours Children under 12 years: Do not use

Storage and handling

each 40 ml contains: sodium 44 mg store between 20-25C°(68-77°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 50 mg

Purpose (in each bottle)

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • sneezing
    • itchy, watery eyes
    • itching of the nose and throat
  • temporarily relieves these symptoms due to the common cold:
    • runny nose
    • sneezing

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not use

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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

OTC - WHEN USING SECTION

When using this product

  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health care professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 12 years and over:
    • swallow the contents of one bottle
    • repeat every 4-6 hours while symptoms persist, or as directed by doctor
    • do not take more than 6 bottles in 24 hours
  • Children under 12 years: Do not use

Other information

STORAGE AND HANDLING SECTION

  • each 40 ml contains: sodium 44 mg
  • store between 20-25C°(68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, flavor, glycerol, polyoxyl 40 stearate, purified water, sodium benzoate, sodium citrate, sucrose

Questions or comments?

OTC - QUESTIONS SECTION

1-877-958-8331 (Monday-Friday 9AM-5PM PST). You may also report serious side effects to this number.

SPL UNCLASSIFIED SECTION

Distributed by
First Aid Shot Therapy®
Burlingame, CA 94010

PRINCIPAL DISPLAY PANEL - 40mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ALLERGY

FAST
–LIQUID–
RELIEF®

FIRST AID
SHOT THERAPY®

TROPICAL

FDA
COMPLIANT

Diphenhydramine HCl
(Antihistamine)

1.35 FL OZ (40mL)

Principal Display Panel - 40mL Bottle Label
Principal Display Panel - 40mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049884diphenhydrAMINE HCl 50 MG in 40 mL Oral SolutionPSN1
1049884diphenhydramine hydrochloride 1.25 MG/ML Oral SolutionSCD1
1049884diphenhydramine hydrochloride 50 MG per 40 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
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57815-010-012020-01-31C16284748780-19d75b9d0-40c9-f424-e053-dadaa90a57ceFirst Aid Shot Therapy ® Allergy Relief ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57815-010-01First Aid Shot Therapy Allergy Relief40 mL in 1 BOTTLE, PLASTICSOLUTION401
57815-010-01First Aid Shot Therapy Allergy Relief1 in 1 CARTONSOLUTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57815-010FIRST AID SHOT THERAPY ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [FIRST AID BEVERAGES, INC.]1Legacy NDC, 2 package rows20160701_af7c4f91-a3d8-4c16-b82c-7e9867986d0b.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57815-01057815-010-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

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
03980abd-259f-40df-86f1-38f386edabdfaf7c4f91-a3d8-4c16-b82c-7e9867986d0b2016-06-20WarningsExact identifier
spl id: 03980abd-259f-40df-86f1-38f386edabdf
spl set id: af7c4f91-a3d8-4c16-b82c-7e9867986d0b

Reported adverse events (FAERS/openFDA)#

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