First Aid Shot Therapy Cold Relief
FDA Label NDC 57815-031

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 Cold Relief (NDC 57815-031). 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, sore throat warning, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, 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 ingredientsPurposes
Dextromethorphan HBR 20 mgCough suppressant
Phenylephrine HCL 10 mgNasal decongestant
Menthol 8.5 mgOral anesthetic

Uses

temporarily relieves

  • nasal and sinus congestion
  • cough due to minor throat and bronchial irritation
  • occasional minor irritation or sore throat

Sore Throat Warning

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea or vomiting, consult a doctor promptly.

Do Not Use

  • If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask A Doctor Before Use If You Have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • cough that lasts or is chronic such as occurs with smoking, asthma and emphysema
  • cough accompanied by excessive phlegm (mucus)

When Using This Product

  • do not exceed recommended dosage

Stop Use And Ask A Doctor If

  • nervousness, dizziness, or sleeplessness occurs
  • cough gets worse or lasts more than 7 days
  • cough comes back or occurs with a fever, rash or persistent headache
  • symptoms do not improve within 7 days or occur with a fever
  • sore mouth symptoms do not improve in 7 days.

    • These could be signs of a serious condition

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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs of symptoms.

Directions

For adults and children 12 years and over:

  • Swallow the contents of one bottle every 4 hours

    • Children 4 to under 12 years:

    • Ask a doctor

      • Children under 4 years:

      • Do not use

Other Information

  • store at controlled room temperature 20-25°C (68-77°F)

Inactive Ingredients

carboxymethylcellulose sodium, citric acid, natural flavors, pectin, purified water, sodium benzoate, sucralose

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

COLD

FAST
–LIQUID–
RELIEF®

FIRST AID
SHOT THERAPY®

ELDERBERRY & MENTHOL

FDA
COMPLIANT

dextromethorphan, phenylephrine &
menthol; cough suppressant, nasal
decongestant, oral anesthetic

1.35 FL OZ (40mL)

Principal Display Panel (40 mL Bottle Label)

Principal Display Panel (40 mL Bottle Label)

* Please review the disclaimer below.