Amazon Nighttime Cold & Flu Drug Facts
f4497e56-c69d-4ae9-bd81-80bf2ee1b17f
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Acetaminophen 325 mg Dextromethorphan HBr 15 mg Doxylamine succinate 6.25 mg
Purpose
Pain reliever/fever reducer Cough suppressant Antihistamine
Medication Information
Purpose
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Description
Acetaminophen 325 mg Dextromethorphan HBr 15 mg Doxylamine succinate 6.25 mg
Uses
temporarily relieves common cold/flu symptoms:
-
•cough due to minor throat and bronchial irritation
-
•sore throat
-
•headache
-
•minor aches and pains
-
•fever
-
•runny nose and sneezing
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, lasts 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 4 doses per 24 hours
|
adults & children 12 yrs & over |
2 softgels with water every 6 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
Other Information
-
•store at 20-25°C (68-77°F)
Inactive Ingredients
D&C yellow no. 10, edible ink*, FD&C blue no. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution *may contain this ingredient
Questions Or Comments?
1-800-719-9260
When Using This Product
-
•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
-
•pain 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.
Ask A Doctor Before Use If You Have
-
•liver disease
-
•glaucoma
-
•cough that occurs with too much phlegm (mucus)
-
•a breathing problem such as emphysema or chronic bronchitis
-
•persistent or chronic cough as occurs with smoking, asthma, or emphysema
-
•trouble urinating due to an enlarged prostate gland
Active Ingredients (in Each Softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg
Package/label Principal Display Panel
Multi-Symptom Relief
Compare to Vicks® NyQuil® Cold & Flu active ingredients
Nighttime Cold & Flu
Acetaminophen, Dextromethorphan HBr
Doxylamine Succinate
Pain Reliever/Fever Reducer, Antihistamine
Cough Suppressant
Alcohol Free
actual size
48 SOFTGELS
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:
-
•cough due to minor throat and bronchial irritation
-
•sore throat
-
•headache
-
•minor aches and pains
-
•fever
-
•runny nose and sneezing
Purpose
Pain reliever/fever reducer
Cough suppressant
Antihistamine
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, lasts 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 4 doses per 24 hours
|
adults & children 12 yrs & over |
2 softgels with water every 6 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
Other Information (Other information)
-
•store at 20-25°C (68-77°F)
Inactive Ingredients (Inactive ingredients)
D&C yellow no. 10, edible ink*, FD&C blue no. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution *may contain this ingredient
Questions Or Comments? (Questions or comments?)
1-800-719-9260
When Using This Product (When using this product)
-
•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)
-
•pain 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.
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
-
•liver disease
-
•glaucoma
-
•cough that occurs with too much phlegm (mucus)
-
•a breathing problem such as emphysema or chronic bronchitis
-
•persistent or chronic cough as occurs with smoking, asthma, or emphysema
-
•trouble urinating due to an enlarged prostate gland
Active Ingredients (in Each Softgel) (Active ingredients (in each softgel))
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg
Package/label Principal Display Panel (Package/Label Principal Display Panel)
Multi-Symptom Relief
Compare to Vicks® NyQuil® Cold & Flu active ingredients
Nighttime Cold & Flu
Acetaminophen, Dextromethorphan HBr
Doxylamine Succinate
Pain Reliever/Fever Reducer, Antihistamine
Cough Suppressant
Alcohol Free
actual size
48 SOFTGELS
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: 2026-02-15T12:03:50.253974 · Updated: 2026-03-14T23:04:07.088578