First Aid Shot Therapy®

SPL v1

SPL

SPL Set ID af7c4f91-a3d8-4c16-b82c-7e9867986d0b

Route

ORAL

Published

Effective Date 2016-06-22

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (50 mg)

Inactive Ingredients

Polyoxyl 40 Stearate Glycerin Trisodium Citrate Dihydrate Anhydrous Citric Acid Sodium Benzoate Sucrose Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2016-07-01

Description

Drug Facts

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Drug Facts

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

Section 42229-5

Drug Facts

Section 50565-1

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

Section 50567-7

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

Section 50568-5

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

Section 50569-3

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

Section 50570-1

Do not use

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

Section 53414-9

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

Directions

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

Active Ingredient

Diphenhydramine HCl 50 mg

Other Information

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

Inactive Ingredients

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

Questions Or Comments?

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

Purpose (in Each Bottle)

Antihistamine

Principal Display Panel 40ml Bottle Label

ALLERGY

FAST

–LIQUID–

RELIEF^®

FIRST AID

SHOT THERAPY^®

TROPICAL

FDA

COMPLIANT

Diphenhydramine HCl

(Antihistamine)

1.35 FL OZ (40mL)

Structured Label Content

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50567-7 (50567-7)

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

Section 50568-5 (50568-5)

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

Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

Do not use

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

Section 53414-9 (53414-9)

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

Directions

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

Active Ingredient (Active ingredient)

Diphenhydramine HCl 50 mg

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

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

Purpose (in Each Bottle) (Purpose (in each bottle))

Antihistamine

Principal Display Panel 40ml Bottle Label (PRINCIPAL DISPLAY PANEL - 40mL Bottle Label)

ALLERGY

FAST

–LIQUID–

RELIEF^®

FIRST AID

SHOT THERAPY^®

TROPICAL

FDA

COMPLIANT

Diphenhydramine HCl

(Antihistamine)

1.35 FL OZ (40mL)

Advanced Ingredient Data

[{"name": "Diphenhydramine", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "50", "strengthDenominator": "40", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "POLYOXYL 40 STEARATE", "unii": "13A4J4NH9I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRISODIUM CITRATE DIHYDRATE", "unii": "B22547B95K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCROSE", "unii": "C151H8M554", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "50567-7": "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", "50568-5": "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers", "50569-3": "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", "50570-1": "Do not use to make a child sleepy with any other product containing diphenhydramine, even one used on skin", "53414-9": "If pregnant or breast-feeding, ask a health care professional before use.", "Directions": "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", "Active ingredient": "Diphenhydramine HCl 50 mg", "Other information": "each 40 ml contains: sodium 44 mg store between 20-25C°(68-77°F)", "Inactive ingredients": "citric acid, flavor, glycerol, polyoxyl 40 stearate, purified water, sodium benzoate, sodium citrate, sucrose", "Questions or comments?": "1-877-958-8331 (Monday-Friday 9AM-5PM PST). You may also report serious side effects to this number.", "Purpose (in each bottle)": "Antihistamine", "PRINCIPAL DISPLAY PANEL - 40mL Bottle Label": "ALLERGY FAST –LIQUID– RELIEF ® FIRST AID SHOT THERAPY ® TROPICAL FDA COMPLIANT Diphenhydramine HCl (Antihistamine) 1.35 FL OZ (40mL)"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:56:08.103471 · Updated: 2026-03-14T22:54:22.435915