first aid shot therapy®

SPL v1

SPL

SPL Set ID 43af9e87-66f9-4a95-8504-7fa352e683a9

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

alcohol 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

Purpose

Nighttime sleep-aid

Description

Drug Facts

Medication Information

Uses

for the relief of occasional sleeplessness
reduces time to fall asleep if you have difficulty falling asleep

Purpose

Nighttime sleep-aid

Directions

Adults and children 12 years and over:

One dose = one bottle (40 mL) at bedtime if needed or as directed by a doctor

Children under 12 years:

Do not use

Other Information

each 40mL contains: sodium 42 mg
store between 20-25C°(68-77°F)

Inactive Ingredients

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

Description

Drug Facts

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 50568-5

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

Section 53414-9

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

Do Not Use

for children under 12 years of age
with any other product containing diphenhydramine, even one used on skin
with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products
with other Nighttime products

Active Ingredients

Diphenhydramine HCl 50 mg

Questions Or Comments?

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

When Using This Product

avoid alcoholic beverages

Purpose (in Each Bottle)

Nighttime sleep-aid

Stop Use and Ask A Doctor If

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.

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

Principal Display Panel 40 Ml Bottle Label

SLEEP

AID

FAST

–LIQUID–

RELIEF ^®

FIRST AID

SHOT THERAPY^®

WARMING PEACH

FDA

COMPLIANT

Diphenhydramine HCl

Nighttime sleep-aid

Alcohol 10%

1.35 FL OZ (40mL)

Structured Label Content

Uses

for the relief of occasional sleeplessness
reduces time to fall asleep if you have difficulty falling asleep

Directions

Adults and children 12 years and over:

One dose = one bottle (40 mL) at bedtime if needed or as directed by a doctor

Children under 12 years:

Do not use

Other Information (Other information)

each 40mL contains: sodium 42 mg
store between 20-25C°(68-77°F)

Inactive Ingredients (Inactive ingredients)

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

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 50568-5 (50568-5)

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

Section 53414-9 (53414-9)

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

Do Not Use (Do not use)

for children under 12 years of age
with any other product containing diphenhydramine, even one used on skin
with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products
with other Nighttime products

Active Ingredients (Active ingredients)

Diphenhydramine HCl 50 mg

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.

When Using This Product (When using this product)

avoid alcoholic beverages

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

Nighttime sleep-aid

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.

Ask A Doctor Before Use If You Have (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

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

SLEEP

AID

FAST

–LIQUID–

RELIEF ^®

FIRST AID

SHOT THERAPY^®

WARMING PEACH

FDA

COMPLIANT

Diphenhydramine HCl

Nighttime sleep-aid

Alcohol 10%

1.35 FL OZ (40mL)

Advanced Ingredient Data

[{"name": "Diphenhydramine", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "50", "strengthDenominator": "40", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"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": "for the relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep", "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.", "50568-5": "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers", "53414-9": "If pregnant or breast-feeding, ask a health care professional before use.", "Directions": "Adults and children 12 years and over: One dose = one bottle (40 mL) at bedtime if needed or as directed by a doctor Children under 12 years: Do not use", "Do not use": "for children under 12 years of age with any other product containing diphenhydramine, even one used on skin with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products with other Nighttime products", "Other information": "each 40mL contains: sodium 42 mg store between 20-25C°(68-77°F)", "Active ingredients": "Diphenhydramine HCl 50 mg", "Inactive ingredients": "alcohol, citric acid, flavors, 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.", "When using this product": "avoid alcoholic beverages", "Purpose (in each bottle)": "Nighttime sleep-aid", "Stop use and ask a doctor if": "sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.", "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", "PRINCIPAL DISPLAY PANEL - 40 mL Bottle Label": "SLEEP AID FAST –LIQUID– RELIEF ® FIRST AID SHOT THERAPY ® WARMING PEACH FDA COMPLIANT Diphenhydramine HCl Nighttime sleep-aid Alcohol 10% 1.35 FL OZ (40mL)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:08.102277 · Updated: 2026-03-14T22:54:22.435915