First Aid Shot Therapy Sleep Aid
FDA Label NDC 57815-091

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by First Aid Beverages, Inc. for the product First Aid Shot Therapy Sleep Aid (NDC 57815-091). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredients, purpose (in each bottle), uses, do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Distributed by
First Aid Shot Therapy®
Burlingame, CA 94010

Active Ingredients

Diphenhydramine HCl 50 mg

Purpose (In Each Bottle)

Nighttime sleep-aid

Uses

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

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

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

Otc - Ask Doctor/Pharmacist

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

When Using This Product

  • avoid alcoholic beverages

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.

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

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

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

Questions Or Comments?

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

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)

Principal Display Panel (40 mL Bottle Label)

Principal Display Panel (40 mL Bottle Label)

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