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  5. Label Information: First Aid Shot Therapy Allergy Relief

FDA Label for First Aid Shot Therapy Allergy Relief

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT
    3. PURPOSE (IN EACH BOTTLE)
    4. USES
    5. OTC - DO NOT USE
    6. OTC - ASK DOCTOR
    7. OTC - ASK DOCTOR/PHARMACIST
    8. OTC - WHEN USING
    9. OTC - PREGNANCY OR BREAST FEEDING
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS OR COMMENTS?
    15. PRINCIPAL DISPLAY PANEL - 40ML BOTTLE LABEL

First Aid Shot Therapy Allergy Relief Product Label

The following document was submitted to the FDA by the labeler of this product First Aid Beverages, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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 - firstaid 01

Principal Display Panel - 40mL Bottle Label - firstaid 01


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