First Aid Shot Therapy Pain Relief
FDA Label NDC 57815-011

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 Pain Relief (NDC 57815-011). 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, otc - purpose, uses, reye's syndrome, stomach bleeding warning, otc - do not use, ask a doctor before use if, otc - ask doctor/pharmacist, 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

Otc - Purpose

Active ingredients (in each bottle)Purpose
Choline salicylate 500mg (NSAID)

nonsteroidal anti-inflammatory drug

Pain reliever/fever reducer
Caffeine 65mgPain reliever aid

Uses

temporarily relieves

  • headache
  • muscle pain
  • toothache
  • menstrual pain
  • pain and fever of colds
  • minor pain of arthritis
  • temporarily reduces fever

Reye's Syndrome

Children and teenagers who have or are recovering from chickenpox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Stomach Bleeding Warning

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed

Otc - Do Not Use

Do not use if you are

  • allergic to salicylates (including aspirin)
  • taking other salicylate products

Ask A Doctor Before Use If

  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • you are taking a diuretic
  • you have asthma

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking a prescription drug for

  • anticoagulation (thinning of the blood)
  • diabetes
  • gout
  • arthritis

Otc - When Using

When using this product limit use of caffeine containing drugs, foods, or drinks, because too much caffeine may cause nervousness, irritability, sleeplessness, and occasional rapid heartbeat

Stop Use And Ask A Doctor If

  • an allergic reaction occurs (seek medical help right away)
  • ringing in the ears or loss of hearing occurs
  • pain gets worse or lasts for more than 10 days
  • fever lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • you experience any of the following signs of stomach bleeding:
    • feel faint
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health 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

For adults and children 12 years and older:

  • swallow the contents of one bottle
  • repeat every 3-4 hours while symptoms persist
  • do not take more than 8 bottles in 24 hours
  • children under 12 years: do not use

Other Information

  • keep from freezing
  • avoid excessive heat (over 104°F or 40°C)

Inactive Ingredients

citric acid, natural and artificial flavors, purified water, sodium benzoate, sodium citrate, sucralose

Questions?

1-877-958-8331 (Monday-Friday 9AM-5PM PST)

Principal Display Panel - 40Ml Bottle Label

F.A.S.T.
RELIEF

FIRST AID
SHOT THERAPY®

PAIN relief

choline salicylate & caffeine
pain reliever/fever reducer
(NSAID)/pain reliever aid

FDA
COMPLIANT

Berry Flavor

1.35 FL OZ (40mL)

Principal Display Panel (40mL Bottle Label)

Principal Display Panel (40mL Bottle Label)

* Please review the disclaimer below.