418 - Nitetime Cold And Flu Relief
407dc4ae-882d-4a49-8884-ef048bb404cf
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Acetaminophen 325mg Dextromethorphan HBr 15mg Doxylamine succinate 6.25mg
Purpose
Pain reliever/fever reducer Cough suppressant Antihistamine
Medication Information
Purpose
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Description
Acetaminophen 325mg Dextromethorphan HBr 15mg Doxylamine succinate 6.25mg
Use(s)
temporarily relieves common cold/flu symptoms:
• cough due to minor throat & bronchial irritation • sore throat • headache
• minor aches & pains • fever • runny nose & sneezing
Warnings
Liver warning: This product contains acetaminophen.
Severe liver damage may occur if you take:
• more than 4 doses in 24 hrs, which is the maximum daily amount for this product
• 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,
occurs with or is followed by fever, headache, rash, nausea, or vomiting,
consult a doctor promptly.
Directions
- take only as directed
- do not exceed 4 doses per 24 hours
Adults and children 12 years and over: 2 softgels with water every 6 hours
Children 4 to under 12 years of age: ask a doctor
Children under 4 years of age: 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.
• to make a child sleep
Other Information
- store at room temperature 20-25 °C (68-77° F)
- do not use if blister unit is torn or open
Questions/comments
Call 1-888-952-0050 Monday through Friday 9AM - 5PM
Active Ingredient(s)
Acetaminophen 325mg
Dextromethorphan HBr 15mg
Doxylamine succinate 6.25mg
Inactive Ingredients
D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene
glycol, purified water, sorbitol sorbitan solution, white edible ink
Principal Display Panel
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 & tranquilizers may increase drowsiness
Ask A Doctor Before Use If
• liver disease
•glaucoma
• cough that occurs with too much phlegm (mucus)
• a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
• trouble urinating due to enlarged prostate gland
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 Breastfeeding,
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
(1-800-222-1222) right away. 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 Or Pharmacist Before Use If
• taking sedatives or tranquilizers
• taking the blood thinning drug warfarin
Structured Label Content
Use(s)
temporarily relieves common cold/flu symptoms:
• cough due to minor throat & bronchial irritation • sore throat • headache
• minor aches & pains • fever • runny nose & 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 doses in 24 hrs, which is the maximum daily amount for this product
• 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,
occurs with or is followed by fever, headache, rash, nausea, or vomiting,
consult a doctor promptly.
Directions
- take only as directed
- do not exceed 4 doses per 24 hours
Adults and children 12 years and over: 2 softgels with water every 6 hours
Children 4 to under 12 years of age: ask a doctor
Children under 4 years of age: 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.
• to make a child sleep
Other Information (Other information)
- store at room temperature 20-25 °C (68-77° F)
- do not use if blister unit is torn or open
Questions/comments (Questions/Comments)
Call 1-888-952-0050 Monday through Friday 9AM - 5PM
Active Ingredient(s) (Active ingredient(s))
Acetaminophen 325mg
Dextromethorphan HBr 15mg
Doxylamine succinate 6.25mg
Inactive Ingredients (Inactive ingredients)
D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene
glycol, purified water, sorbitol sorbitan solution, white edible ink
Principal Display Panel
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 & tranquilizers may increase drowsiness
Ask A Doctor Before Use If (Ask a doctor before use if)
• liver disease
•glaucoma
• cough that occurs with too much phlegm (mucus)
• a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
• trouble urinating due to enlarged prostate gland
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 Breastfeeding, (If pregnant or breastfeeding,)
ask a health professional before use.
Keep Out of Reach of Children (Keep out of reach of children)
In case of overdose, get medical help or contact a Poison Control Center
(1-800-222-1222) right away. 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 Or Pharmacist Before Use If (Ask a doctor or pharmacist before use if)
• 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: 2026-02-15T12:02:12.847282 · Updated: 2026-03-14T23:01:38.303933