418-nighttime cold and flu relief
b97126d7-847d-483e-b3d1-e2b61ab1743f
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Purpose
Pain reliever/fever reducer Cough suppressant Antihistamine
Description
Acetaminophen 325mg Dextromethorphan HBr 15mg Doxylamine succinate 6.25mg
Medication Information
Warnings
Liver warning: This product contains acetaminophen. Severe
liver damage may occur if you take:
- more than 4 doses in 24 hours, 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 sever 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.
Purpose
Pain reliever/fever reducer
Cough suppressant
Antihistamine
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
Other Information
Do not use if blister unit is torn or open
Inactive Ingredients
D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution
May contain: sorbitol 70% solution, titanium dioxide, white edible ink
Description
Acetaminophen 325mg Dextromethorphan HBr 15mg Doxylamine succinate 6.25mg
Principal Display Panel
Use(s)
temporarily relieves common cold and flu symptoms:
- cough due to minor throat and bronchial irritation
- sore throat
- headache
- minor aches and pains
- fever
- runny nose and sneezing
Storage
- store at room temperature 20-25 °C (68-77° F)
Questions
Call 1-888-952-0050 Monday through Friday
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 drugs. 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
Active Ingredient(s)
Acetaminophen 325mg
Dextromethorphan HBr 15mg
Doxylamine succinate 6.25mg
Pregnancy/breastfeeding
ask a health professional before use.
When Using This Product
- excitability may occur, especially in children
- marked drowsiness may occur
- avoid alcoholic drink
- be careful when driving a motor vehicle or operating machinery
- alcohol, sedatives, and 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 an enlarged prostate gland
Stop Use and Ask A Doctor If
- pain 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.
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
Warnings
Liver warning: This product contains acetaminophen. Severe
liver damage may occur if you take:
- more than 4 doses in 24 hours, 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 sever 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.
Purpose
Pain reliever/fever reducer
Cough suppressant
Antihistamine
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
Other Information (Other information)
Do not use if blister unit is torn or open
Inactive Ingredients (Inactive ingredients)
D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution
May contain: sorbitol 70% solution, titanium dioxide, white edible ink
Principal Display Panel
Use(s)
temporarily relieves common cold and flu symptoms:
- cough due to minor throat and bronchial irritation
- sore throat
- headache
- minor aches and pains
- fever
- runny nose and sneezing
Storage
- store at room temperature 20-25 °C (68-77° F)
Questions
Call 1-888-952-0050 Monday through Friday
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 drugs. 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
Active Ingredient(s) (Active ingredient(s))
Acetaminophen 325mg
Dextromethorphan HBr 15mg
Doxylamine succinate 6.25mg
Pregnancy/breastfeeding (Pregnancy/Breastfeeding)
ask a health professional before use.
When Using This Product (When using this product)
- excitability may occur, especially in children
- marked drowsiness may occur
- avoid alcoholic drink
- be careful when driving a motor vehicle or operating machinery
- alcohol, sedatives, and 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 an enlarged prostate gland
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
- pain 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.
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
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Raw Label Data
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Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:02:21.495676 · Updated: 2026-03-14T23:14:11.403934