Uses temporarily relieves common cold and flu symptoms: minor aches and pains sinus congestion and pressure sore throat fever headache nasal congestion cough due to minor throat and bronchial irritation cough to help you sleep runny nose and sneezing reduces swelling of nasal passages promotes nasal and/or sinus drainage temporarily restores freer breathing through the nose
Directions do not take more than directed do not take more than 8 caplets in 24 hours adults and children 12 years and over: take 2 caplets with water every 4 hours children under 12 years: ask a doctor
Drug Facts
Active Ingredients (in each caplet)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Doxylamine succinate 6.25 mg
Phenylephrine HCl 5 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
Questions or comments? 1-877-507-6516
[24/7 Life 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*
16
CAPLETS
Actual Size [caplet image]
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1546881 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | 2 |
| 1546881 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | 2 |
| 1546881 | APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral Tablet | SY | 2 |
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| DOXYLAMINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 66715-6516-8 | Cold and Flu Nighttime Severe, 24-7 Life | 8 in 1 BLISTER PACK | TABLET, FILM COATED | 8 | 2 | |
| 66715-6516-8 | Cold and Flu Nighttime Severe, 24-7 Life | 2 in 1 CARTON | TABLET, FILM COATED | 2 | 2 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 66715-6516 | COLD AND FLU NIGHTTIME SEVERE, 24-7 LIFE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC.] | 2 | Current NDC, 2 package rows | 20241218_05d0410f-164e-e7ee-e063-6394a90a2aaa.zip |
| Product NDC | Package NDC |
|---|---|
| 66715-6516 | 66715-6516-8 |
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Cold and Flu Nighttime Severe, 24-7 Life | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Lil' Drug Store products, Inc. | 05d0410f-164e-e7ee-e063-6394a90a2aaa | 2024-12-16 | Warnings |
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings Warnings Liver warning Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy alert Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: blisters rash skin reddening If a skin reaction occurs, stop use and seek medical help right away. Sore throat warning 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 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. if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use Ask a doctor before use if you have liver disease diabetes thyroid disease heart disease glaucoma high blood pressure difficulty in urination due to enlargement of the prostate gland a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers taking the blood thinning drug warfarin When using this product When using this product do not exceed recommended dosage excitability may occur, especially in children marked drowsiness may occur avoid alcoholic beverages be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness Stop use and ask a doctor Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is presen new symptoms occur cough comes back...