Cough And Cold Plus

Cough And Cold Plus
SPL v3
SPL
SPL Set ID c483d88f-cb0a-4dd6-b3ae-559521782ba6
Route
ORAL
Published
Effective Date 2019-11-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Phenylephrine (5 mg) Chlorpheniramine (2 mg) Dextromethorphan (10 mg)
Inactive Ingredients
Butylated Hydroxyanisole D&c Red No. 33 Fd&c Blue No. 1 Gelatin Glycerin Polyethylene Glycol, Unspecified Povidone Propylene Glycol Sorbitan Sorbitol Water

Identifiers & Packaging

Pill Appearance
Imprint: P18 Shape: capsule Color: purple Size: 21 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-03-24

Description

Acetaminophen 325 mg Chlorpheniramine maleate 2 mg Dextromethorphan hydrobromide 10 mg Phenylephrine hydrochloride 5 mg

Purpose

Pain reliever/fever reducer Antihistamine Cough suppressant Nasal decongestant


Medication Information

Purpose

Pain reliever/fever reducer

Antihistamine

Cough suppressant

Nasal decongestant

Description

Acetaminophen 325 mg Chlorpheniramine maleate 2 mg Dextromethorphan hydrobromide 10 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
  • runny nose
  • sneezing
  • sore throat
  • temporarily reduces fever
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. 

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 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

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.

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 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.  
  • 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°F-86°F) and avoid excessive heat.
Inactive Ingredients

Butylated Hydroxyanisole (BHA), D&C red #33, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, white ink 

Questions Or Commonts

Call toll free: 1-855-215-8180

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 Softgel)

Acetaminophen 325 mg

Chlorpheniramine maleate 2 mg

Dextromethorphan hydrobromide 10 mg

Phenylephrine hydrochloride 5 mg

Principal Display Panel Shipping Label

Cough and Cold plus Capsules

Each softgel contains: Acetaminophen 325 mg Phenylephrine HCl 5 mg

Chlorpheniramine Maleate 2 mg Dextromethorphan HBr 10 mg

Quantity: 4000 Capsules

NDC No.:53345-045-01

MADE IN CHINA

IMPORTANT:

  • Inspect immediately upon receipt.
  • This is a bulk shipment, intended for further processing only.
  • Protect from heat, humidity, and light. Do not refrigerate.
  • 4.Store at 15-30°C (59-86)°F

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
  • runny nose
  • sneezing
  • sore throat
  • temporarily reduces fever
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. 

Section 53414-9 (53414-9)

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

Purpose

Pain reliever/fever reducer

Antihistamine

Cough suppressant

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

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.

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 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.  
  • 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°F-86°F) and avoid excessive heat.
Inactive Ingredients (Inactive ingredients)

Butylated Hydroxyanisole (BHA), D&C red #33, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, white ink 

Questions Or Commonts (Questions or commonts)

Call toll free: 1-855-215-8180

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 Softgel) (Active ingredients (in each softgel))

Acetaminophen 325 mg

Chlorpheniramine maleate 2 mg

Dextromethorphan hydrobromide 10 mg

Phenylephrine hydrochloride 5 mg

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

Cough and Cold plus Capsules

Each softgel contains: Acetaminophen 325 mg Phenylephrine HCl 5 mg

Chlorpheniramine Maleate 2 mg Dextromethorphan HBr 10 mg

Quantity: 4000 Capsules

NDC No.:53345-045-01

MADE IN CHINA

IMPORTANT:

  • Inspect immediately upon receipt.
  • This is a bulk shipment, intended for further processing only.
  • Protect from heat, humidity, and light. Do not refrigerate.
  • 4.Store at 15-30°C (59-86)°F

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

All Sections (JSON)