First Aid Shot Therapy Allergy Relief
FDA Label NDC 57815-010

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 Allergy Relief (NDC 57815-010). 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 ingredient, purpose (in each bottle), uses, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, 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 Ingredient

Diphenhydramine HCl 50 mg

Purpose (In Each Bottle)

Antihistamine

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

Otc - Do Not Use

Do not use

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

Otc - Ask Doctor

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

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

Otc - When Using

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

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:
    • 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

  • 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.

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)

Principal Display Panel (40mL Bottle Label)

Principal Display Panel (40mL Bottle Label)

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