Drug Facts
Drug Facts
The following Structured Product Label (SPL) was submitted to the FDA by Lil' Drug Store Products, Inc. for the product Nighttime Severe, Cold And Flu, 24-7 Life By 7-eleven (NDC 66715-6505). 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 drug facts, active ingredients, purpose, uses, warnings, liver warning, allergy alert, sore throat warning, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Active ingredients (in each caplet)
Acetaminophen 325
Dextromethorphan HBr 10 mg
Doxylamine succinate 6.25 mg
Doxylamine succinate 6.25 mg
Purpose
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Nasal decongestant
Uses
Warnings
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
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
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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
Other information
Inactive ingredients
black iron oxide, corn starch, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide
[24/7 Life by 7-ElevenTM logo]
Cold & Flu
Nighttime
Severe
Acetaminophen
Pain Reliever/Fever Reducer
Dextromethorphan HBr / Cough Suppressant
Doxylamine Succinate / Antihistamine
Phenylephrine HCl / Nasal Decongestant
Relieves: Headache, Fever,
Sore Throat, Minor Aches &
Pains, Nasal Congestion, Sinus
Pressure, Sneezing, Runny Nose,
Cough
compare to
Vicks
® NyQuil
®
VapoCOOL™ SEVERE Cold &
Flu + Congestion
active ingredients*
6
CAPLETS
[caplet image]
Actual Size
* Please review the disclaimer below.