Active Ingredients
Active ingredients (in each caplet)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Doxylamine succinate 6.25 mg
The following Structured Product Label (SPL) was submitted to the FDA by Lil' Drug Store Products, Inc. for the product Nyquil Cold And Flu W/vapocool, 4ct, Lil Drug Store (NDC 66715-9605). 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 active ingredients, purpose, uses, liver warning, allergy alert, sore throat warning, do not use, ask a doctor before use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredients (in each caplet)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Doxylamine succinate 6.25 mg
Purpose
Pain reliever/fever red
Cough suppressant
Antihistamine
Uses
temporarily relieves common cold/flu symptoms:
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Do not use
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• 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
Ask a doctor or pharmacist before use if you are
When using this product
Stop use and ask a doctor if
These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a
Poison Control Center right away. Quick medical attention is critical for adults as
well as for children even if you do not notice any signs or symptoms.
Directions
| adults & children 12 yrs & over | 2 caplets with water every 4 hrs |
| children 4 to under 12 yrs | ask a doctor |
| children under 4 yrs | do not use |
Other information
Inactive ingredients
corn starch, D&C Yellow #10 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, stearic acid, sucralose, talc, titanium dioxide
Questions?1-800-362-1683
VICKS
NyQuil ™
COLD & FLU
Acetaminophen, Docylamine
Succinate, Dextromethorphan HBr
[caplet image]
Headache, Fever, Sore Throat,
Minor Aches & Pains
Cough
VapoCOOL
COATED
4 Coated Caplets
[Lil' Drug Store ® logo]
VICKS
NyQuil™
COLD & FLU
Acetaminophen, Docylamine
Succinate, Dextromethorphan HBr
[caplet image]
Headache, Fever, Sore Throat,
Minor Aches & Pains
Cough
VapoCOOL
COATED
4 Coated Caplets
[CVP ® HEALTH logo]
VICKS
NyQuil™
COLD & FLU
Acetaminophen, Docylamine
Succinate, Dextromethorphan HBr
[caplet image]
Headache, Fever, Sore Throat,
Minor Aches & Pains
Cough
VapoCOOL
COATED
4 Coated Caplets
[Travel BASIX logo]
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