Night Time Cold & Flu Formula
42244fed-61a0-4e34-a98b-3225b0ea51c6
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Drug Facts
Purpose
Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant
Medication Information
Purpose
Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant
Description
Drug Facts
Uses
- temporarily relieves these symptoms due to a cold or flu:
- minor aches and pains
- headache
- nasal and sinus congestion
- cough
- sore throat
- runny nose
- sneezing
- temporarily reduces fever
Section 42229-5
Drug Facts
Section 53414-9
If pregnant or breast-feeding, ask a health professional before use.
Purposes
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 10 softgels 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
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.
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.
Do not use to sedate children.
Directions
- do not take more than the recommended dose
- adults and children 12 years and over: take 2 softgels with water every 4 hours. Do not exceed 10 softgels in 24 hours or as directed by a doctor.
- children under 12 years: 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.
- in children under 12 years of age
Other Information
- store at room temperature. Avoid excessive heat.
Inactive Ingredients
D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, and white edible ink
Questions Or Comments?
Call toll free: 1-855-215-8180
Principal Display Panel
NIGHT TIME COLD & FLU FORMULA 20 SOFTGELS
NDC 51013-162-08
*Compare to the active ingredients in Alka-Seltzer PLUS® Night Cold and Flu Formula
When Using This Product
- do not exceed recommended dosage
- may cause marked drowsiness
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
Stop Use and Ask A Doctor If
- pain, cough, or nasal congestion 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.
- nervousness, dizziness, or sleeplessness occurs
Keep Out of Reach of Children.
In case of overdose, get medical help or contact a Poison Control Center 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 Before Use If You Have
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- cough with excessive phlegm (mucus)
- a breathing problem such as emphysema or chronic bronchitis
- difficulty in urination due to enlargement of the prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
Active Ingredients (in Each Softgel)
Acetaminophen 325 mg
Dextromethorphan hydrobromide 10 mg
Doxylamine succinate 6.25 mg
Phenylephrine hydrochloride 5 mg
Ask A Doctor Or Pharmacist Before Use If You Are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
Structured Label Content
Uses
- temporarily relieves these symptoms due to a cold or flu:
- minor aches and pains
- headache
- nasal and sinus congestion
- cough
- sore throat
- runny nose
- sneezing
- temporarily reduces fever
Section 42229-5 (42229-5)
Drug Facts
Section 53414-9 (53414-9)
If pregnant or breast-feeding, ask a health professional before use.
Purposes
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 10 softgels 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
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.
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.
Do not use to sedate children.
Directions
- do not take more than the recommended dose
- adults and children 12 years and over: take 2 softgels with water every 4 hours. Do not exceed 10 softgels in 24 hours or as directed by a doctor.
- children under 12 years: 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.
- in children under 12 years of age
Other Information (Other information)
- store at room temperature. Avoid excessive heat.
Inactive Ingredients (Inactive ingredients)
D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, and white edible ink
Questions Or Comments? (Questions or comments?)
Call toll free: 1-855-215-8180
Principal Display Panel (PRINCIPAL DISPLAY PANEL)
NIGHT TIME COLD & FLU FORMULA 20 SOFTGELS
NDC 51013-162-08
*Compare to the active ingredients in Alka-Seltzer PLUS® Night Cold and Flu Formula
When Using This Product (When using this product)
- do not exceed recommended dosage
- may cause marked drowsiness
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
- pain, cough, or nasal congestion 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.
- nervousness, dizziness, or sleeplessness occurs
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 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 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 with excessive phlegm (mucus)
- a breathing problem such as emphysema or chronic bronchitis
- difficulty in urination due to enlargement of the prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
Active Ingredients (in Each Softgel) (Active ingredients (in each softgel))
Acetaminophen 325 mg
Dextromethorphan hydrobromide 10 mg
Doxylamine succinate 6.25 mg
Phenylephrine hydrochloride 5 mg
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
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Raw Label Data
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Additional Information
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Source: dailymed · Ingested: 2026-02-15T11:56:57.356818 · Updated: 2026-03-14T22:55:46.109144