Nighttime Cold And Flu Capsule, Liquid Filled
a01abac3-c13e-40f2-ae98-34bd6c9b7504
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 & bronchial irritation
- sore throat
- headache
- minor aches/pains
- fever
- runny nose & sneezing
Section 50565-1
Keep out of reach of children.
Overdose warning: Taking more than the recommended dose (overdose) could cause serious health problems.In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms .
Section 50566-9
Stop use and Ask a doctor if
- you get nervous, dizzy, or sleepless
- swelling or redness is present
- symptoms do not get better or are accompanied by a fever that lasts more than 3 days or if new symptoms occur
- cough lasts more than 7 days (adults) or 5 days (children), recurs or is accompanied by fever, rash, or persistent headache.
These may be signs of a serious condition.
Section 50570-1
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
Section 53414-9
If pregnant or breast-feeding,ask a health professional before use.
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
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily while using this product
Sore throat warning:If sore throat is severe, persists 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 and children 12 years of age and over |
Swallow 2 softgels with water every 6 hours |
|
Children 4 to 12 years of age |
ask a doctor |
|
children under4 years o9f age |
do not use |
If taking NIGHTTIME and DAYTIME softgels carefully read each label to insure correct dosing.
Other Information
- store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat
- this product does not contain phenylpropanolamine (PPA)
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
Manufactured by:
Humanwell PuraCap Pharmaceutical (Wuhan) Ltd.
Wuhan, Hubei
430206, China
When Using This Product
- do not exceed the recommended dosage
- do not use for more than 7 days
- excitability may occur especially in children
- marked drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
Ask A Doctor Before Use If You Have
- liver disease
- glaucoma
- cough with excessive phlegm(mucus)
- a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
- difficulty in urinating due to an enlarged prostate gland
Active Ingredients (in Each Capsule)
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine Succinate 6.25 mg
Principal Display Panel Shipping Label
NIGHTTIME COLD AND FLU CAPSULES
Quantity : 4000 Capsules
NDC. No : 53345-006-01
IMPORTANT:
Inspect immediate upon receipt.
This is a bulk shipment intended for further processing only.
Protect from heat, humidity, and light. Do not refrigerate.
CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING"
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 & bronchial irritation
- sore throat
- headache
- minor aches/pains
- fever
- runny nose & sneezing
Section 50565-1 (50565-1)
Keep out of reach of children.
Overdose warning: Taking more than the recommended dose (overdose) could cause serious health problems.In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms .
Section 50566-9 (50566-9)
Stop use and Ask a doctor if
- you get nervous, dizzy, or sleepless
- swelling or redness is present
- symptoms do not get better or are accompanied by a fever that lasts more than 3 days or if new symptoms occur
- cough lasts more than 7 days (adults) or 5 days (children), recurs or is accompanied by fever, rash, or persistent headache.
These may be signs of a serious condition.
Section 50570-1 (50570-1)
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
Section 53414-9 (53414-9)
If pregnant or breast-feeding,ask a health professional before use.
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 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily while using this product
Sore throat warning:If sore throat is severe, persists 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 and children 12 years of age and over |
Swallow 2 softgels with water every 6 hours |
|
Children 4 to 12 years of age |
ask a doctor |
|
children under4 years o9f age |
do not use |
If taking NIGHTTIME and DAYTIME softgels carefully read each label to insure correct dosing.
Other Information (Other information)
- store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat
- this product does not contain phenylpropanolamine (PPA)
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
Manufactured by:
Humanwell PuraCap Pharmaceutical (Wuhan) Ltd.
Wuhan, Hubei
430206, China
When Using This Product (When using this product)
- do not exceed the recommended dosage
- do not use for more than 7 days
- excitability may occur especially in children
- marked drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
- liver disease
- glaucoma
- cough with excessive phlegm(mucus)
- a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
- difficulty in urinating due to an enlarged prostate gland
Active Ingredients (in Each Capsule) (Active ingredients (in each capsule))
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine Succinate 6.25 mg
Principal Display Panel Shipping Label (PRINCIPAL DISPLAY PANEL - Shipping Label)
NIGHTTIME COLD AND FLU CAPSULES
Quantity : 4000 Capsules
NDC. No : 53345-006-01
IMPORTANT:
Inspect immediate upon receipt.
This is a bulk shipment intended for further processing only.
Protect from heat, humidity, and light. Do not refrigerate.
CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING"
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
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Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:04:30.025556 · Updated: 2026-03-14T23:05:17.700396