Label: FIRST AID SHOT THERAPY COLD RELIEF- dextromethorphan hydrobromide, phenylephrine hydrochloride, and menthol solution
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Contains inactivated NDC Code(s)
NDC Code(s): 57815-031-01 - Packager: First Aid Beverages, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated August 27, 2015
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
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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)
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
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 40 mL Bottle Label
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INGREDIENTS AND APPEARANCE
FIRST AID SHOT THERAPY COLD RELIEF
dextromethorphan hydrobromide, phenylephrine hydrochloride, and menthol solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57815-031 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide 20 mg in 40 mL Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride 10 mg in 40 mL Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol 8.5 mg in 40 mL Inactive Ingredients Ingredient Name Strength 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 Shape Size Flavor MENTHOL Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57815-031-01 40 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 05/01/2015 Labeler - First Aid Beverages, Inc. (078618157)
