Night Cold Flu Cough And Allergy Capsule, Liquid Filled

Night Cold Flu Cough And Allergy Capsule, Liquid Filled
SPL v3
SPL
SPL Set ID 590f4f0d-c8b0-412d-be1e-3eb2ccb29ac0
Route
ORAL
Published
Effective Date 2019-11-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg) Doxylamine (6.25 mg) Phenylephrine (5 mg)
Inactive Ingredients
D&c Yellow No. 10 Fd&c Blue No. 1 Gelatin Glycerin Polyethylene Glycol, Unspecified Povidone Propylene Glycol Water Sorbitol

Identifiers & Packaging

Pill Appearance
Imprint: PC22 Shape: capsule Color: green Size: 21 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-05-29

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine Succinate 6.25 mg Phenylephrine Hydrochloride 5 mg

Purpose

Pain reliever/ fever reducer Cough suppressant  Antihistamine Nasal decongestant


Medication Information

Purpose

Pain reliever/ fever reducer

Cough suppressant 

Antihistamine

Nasal decongestant

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine Succinate 6.25 mg Phenylephrine Hydrochloride 5 mg

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 42228-7

If pregnant or breast-feeding,ask a health professional before use.

Section 50565-1

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.

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.

Do not use to sedate children.

Directions
  • do not take more than the recommended dose
  • adults and children 12 years of age 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 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.
  • if you have ever had an allergic reaction to this product or any of its ingredients
  •  in children under 12 years of age
Other Information
  • store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat
Inactive Ingredients

FD&C blue #1, D&C yellow #10, 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 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                                                                                   
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 Capsule)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine Succinate 6.25 mg

Phenylephrine Hydrochloride 5 mg

Principal Display Panel Shipping Label

NIGHTTIME COLD AND FLU CAPSULES

Quantity : 4000 Capsules

NDC. No : 53345-020-01

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 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 42228-7 (42228-7)

If pregnant or breast-feeding,ask a health professional before use.

Section 50565-1 (50565-1)

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.

Purpose

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.

Do not use to sedate children.

Directions
  • do not take more than the recommended dose
  • adults and children 12 years of age 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 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.
  • if you have ever had an allergic reaction to this product or any of its ingredients
  •  in children under 12 years of age
Other Information (Other information)
  • store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat
Inactive Ingredients (Inactive ingredients)

FD&C blue #1, D&C yellow #10, 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 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                                                                                   
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 Capsule) (Active ingredients (in each capsule))

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine Succinate 6.25 mg

Phenylephrine Hydrochloride 5 mg

Principal Display Panel Shipping Label (PRINCIPAL DISPLAY PANEL - Shipping Label)

NIGHTTIME COLD AND FLU CAPSULES

Quantity : 4000 Capsules

NDC. No : 53345-020-01

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 the blood thinning drug warfarin
  • taking sedatives or tranquilizers                                                                                            

Advanced Ingredient Data


Raw Label Data

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