Nighttime Cold And Flu Capsule, Liquid Filled

Nighttime Cold And Flu Capsule, Liquid Filled
SPL v4
SPL
SPL Set ID a01abac3-c13e-40f2-ae98-34bd6c9b7504
Route
ORAL
Published
Effective Date 2019-08-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (15 mg) Doxylamine (6.25 mg)
Inactive Ingredients
D&c Yellow No. 10 Fd&c Blue No. 1 Gelatin Glycerin Polyethylene Glycol Povidone Propylene Glycol Water Sorbitol

Identifiers & Packaging

Pill Appearance
Imprint: PC10 Shape: capsule Color: green Size: 21 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-04-15

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


Advanced Ingredient Data


Raw Label Data

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