Topco Associates Llc. Nite Time Cold & Flu Drug Facts
a7f9f1d0-7498-461c-b4e8-4c92cf3feae8
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
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
Medication Information
Purpose
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Nasal decongestant
Description
Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg Phenylephrine HCl 5 mg
Uses
-
•temporarily relieves common cold/flu symptoms:
-
•nasal congestion
-
•sinus congestion and pressure
-
•cough due to minor throat and bronchial irritation
-
•cough to help you sleep
-
•minor aches and pains
-
•headache
-
•fever
-
•sore throat
-
•runny nose and sneezing
-
•reduces swelling of nasal passages
-
•temporarily restores freer breathing through the nose
-
•promotes nasal and/or sinus drainage
Warnings
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: Acetaminophen may cause severe skin reactions. Symptoms may include:
-
•skin reddening
-
•blisters
-
•rash
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.
Directions
-
•take only as directed – see overdose warning
-
•do not exceed 8 caplets per 24 hrs
|
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 |
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
Inactive Ingredients
crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, silicon dioxide, stearic acid, sucralose, talc, titanium dioxide
Questions Or Comments?
1-888-423-0139
When Using This Product
-
•do not use more than directed
-
•excitability may occur, especially in children
-
•marked drowsiness may occur
-
•avoid alcoholic drinks
-
•be careful when driving a motor vehicle or operating machinery
-
•alcohol, sedatives, and tranquilizers may increase drowsiness
Stop Use and Ask A Doctor If
-
•you get nervous, dizzy or sleepless
-
•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 present
-
•new symptoms occur
-
•cough comes back or occurs with rash or headache that lasts. 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.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Active Ingredients (in Each Caplet)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Doxylamine succinate 6.25 mg
Phenylephrine HCl 5 mg
Ask A Doctor Before Use If You Have
-
•liver disease
-
•heart disease
-
•high blood pressure
-
•thyroid disease
-
•diabetes
-
•glaucoma
-
•cough that occurs with too much phlegm (mucus)
-
•a breathing problem such as emphysema or chronic bronchitis
-
•persistent or chronic cough such as occurs with smoking, asthma, or emphysema
-
•trouble urinating due to an enlarged prostate gland
Package/label Principal Display Panel
TopCare® health
COMPARE TO VICKS® NYQUIL®
SEVERE+ VAPOCOOL™ ACTIVE INGREDIENTS
VAPOR ICE®
Nite Time Cold & Flu
SEVERE
PAIN RELIEVER-FEVER REDUCER – ACETAMINOPHEN
COUGH SUPPRESSANT – DEXTROMETHORPHAN HBr
ANTIHISTAMINE – DOXYLAMINE SUCCINATE
NASAL DECONGESTANT – PHENYLEPHRINE HCl
• Minor Aches & Pains, Fever
• Nasal Congestion & Sinus Pressure
• Sneezing, Runny Nose • Cough
Maximum Strength
24 CAPLETS
actual size
Ask A Doctor Or Pharmacist Before Use If You Are
-
•taking sedatives or tranquilizers
-
•taking the blood thinning drug warfarin
Structured Label Content
Uses
-
•temporarily relieves common cold/flu symptoms:
-
•nasal congestion
-
•sinus congestion and pressure
-
•cough due to minor throat and bronchial irritation
-
•cough to help you sleep
-
•minor aches and pains
-
•headache
-
•fever
-
•sore throat
-
•runny nose and sneezing
-
•reduces swelling of nasal passages
-
•temporarily restores freer breathing through the nose
-
•promotes nasal and/or sinus drainage
Purpose
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Nasal decongestant
Warnings
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: Acetaminophen may cause severe skin reactions. Symptoms may include:
-
•skin reddening
-
•blisters
-
•rash
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.
Directions
-
•take only as directed – see overdose warning
-
•do not exceed 8 caplets per 24 hrs
|
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 |
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
Inactive Ingredients (Inactive ingredients)
crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, silicon dioxide, stearic acid, sucralose, talc, titanium dioxide
Questions Or Comments? (Questions or comments?)
1-888-423-0139
When Using This Product (When using this product)
-
•do not use more than directed
-
•excitability may occur, especially in children
-
•marked drowsiness may occur
-
•avoid alcoholic drinks
-
•be careful when driving a motor vehicle or operating machinery
-
•alcohol, sedatives, and tranquilizers may increase drowsiness
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
-
•you get nervous, dizzy or sleepless
-
•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 present
-
•new symptoms occur
-
•cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)
ask a health professional before use.
Keep Out of Reach of Children. (Keep out of reach of children.)
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Active Ingredients (in Each Caplet) (Active ingredients (in each caplet))
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Doxylamine succinate 6.25 mg
Phenylephrine HCl 5 mg
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
-
•liver disease
-
•heart disease
-
•high blood pressure
-
•thyroid disease
-
•diabetes
-
•glaucoma
-
•cough that occurs with too much phlegm (mucus)
-
•a breathing problem such as emphysema or chronic bronchitis
-
•persistent or chronic cough such as occurs with smoking, asthma, or emphysema
-
•trouble urinating due to an enlarged prostate gland
Package/label Principal Display Panel (Package/Label Principal Display Panel)
TopCare® health
COMPARE TO VICKS® NYQUIL®
SEVERE+ VAPOCOOL™ ACTIVE INGREDIENTS
VAPOR ICE®
Nite Time Cold & Flu
SEVERE
PAIN RELIEVER-FEVER REDUCER – ACETAMINOPHEN
COUGH SUPPRESSANT – DEXTROMETHORPHAN HBr
ANTIHISTAMINE – DOXYLAMINE SUCCINATE
NASAL DECONGESTANT – PHENYLEPHRINE HCl
• Minor Aches & Pains, Fever
• Nasal Congestion & Sinus Pressure
• Sneezing, Runny Nose • Cough
Maximum Strength
24 CAPLETS
actual size
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
-
•taking sedatives or tranquilizers
-
•taking the blood thinning drug warfarin
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:04:22.657036 · Updated: 2026-03-14T23:05:04.083969