FIRST AID SHOT THERAPY COLD RELIEF- dextromethorphan hydrobromide, phenylephrine hydrochloride, and menthol solution 
First Aid Beverages, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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First Aid Shot Therapy® Cold Relief

Drug Facts

Active ingredientsPurposes
Dextromethorphan HBR 20 mgCough suppressant
Phenylephrine HCL 10 mgNasal decongestant
Menthol 8.5 mgOral anesthetic

Uses

temporarily relieves

Warnings

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

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

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:

Children 4 to under 12 years:

Children under 4 years:

Other information

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.

Distributed by
First Aid Shot Therapy®
Burlingame, CA 94010

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
FIRST AID SHOT THERAPY COLD RELIEF 
dextromethorphan hydrobromide, phenylephrine hydrochloride, and menthol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57815-031
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide20 mg  in 40 mL
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride10 mg  in 40 mL
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol8.5 mg  in 40 mL
Inactive Ingredients
Ingredient NameStrength
Anhydrous Citric Acid (UNII: XF417D3PSL)  
Carboxymethylcellulose sodium, unspecified form (UNII: K679OBS311)  
Pectin (UNII: 89NA02M4RX)  
Sodium Benzoate (UNII: OJ245FE5EU)  
Sucralose (UNII: 96K6UQ3ZD4)  
Water (UNII: 059QF0KO0R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMENTHOLImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57815-031-0140 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34105/01/2015
Labeler - First Aid Beverages, Inc. (078618157)

Revised: 8/2015
Document Id: c4e9b0eb-f6f9-42a7-86dc-c2e6593eac70
Set id: 570f64a6-3486-466a-b98f-f91714a63afa
Version: 2
Effective Time: 20150827
 
First Aid Beverages, Inc.