First Aid Shot Therapy Sleep Aid

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 50 mg

Purpose (in each bottle)

OTC - PURPOSE SECTION

Nighttime sleep-aid

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

• 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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

When using this product

OTC - WHEN USING SECTION

• avoid alcoholic beverages

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

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:

• 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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

alcohol, citric acid, flavors, 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 - 40 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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)

Related RxNorm Concepts#

DailyMed RxNorm Mappings#

DailyMed Pharmacologic Classes#

DailyMed Product Concepts#

FDA-Initiated Inactive NDC Indexing#

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DailyMed Dashboard NDC Coverage#

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

• First Aid Shot Therapy Sleep Aid
• Diphenhydramine Hydrochloride
• Diphenhydramine
• ALCOHOL
• POLYOXYL 40 STEARATE
• GLYCERIN
• TRISODIUM CITRATE DIHYDRATE
• ANHYDROUS CITRIC ACID
• SODIUM BENZOATE
• SUCROSE
• WATER

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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.

Reported adverse events (FAERS/openFDA)#

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