417- daytime cold and flu

417- daytime cold and flu
SPL v3
SPL
SPL Set ID bed5f9dc-45ea-4e90-86c6-86599b6f3861
Route
oral
Published
Effective Date 2020-11-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
acetaminophen (325 mg) dextromethorphan (10 mg) phenylephrine (5 mg)
Inactive Ingredients
fd&c red no. 40 fd&c yellow no. 6 gelatin glycerin polyethylene glycol, unspecified povidone propylene glycol water sorbitol solution

Identifiers & Packaging

Pill Appearance
Imprint: PC9 Shape: capsule Color: orange Size: 21 mm Score: 1
Marketing Status
otc monograph drug active Since 2020-11-11

Purpose

Pain reliever/fever reducer Cough suppressant Nasal decongestant

Description

Acetaminophen 325mg Dextromethorphan HBr 10mg Phenylephrine HCl 5mg


Medication Information

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 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, lasts for more than 2 days, occurs with or followed by fever,  headache, rash, nausea, or vomiting, see a doctor promptly.

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Directions

take only as directed

  • do not exceed 4 doses per 24 hours
  • Adults and children 12 years and over: 2 softgels with water every 4 hours
  • Children 4 to under 12 years: ask a doctor
  • Children under 4 years: do not use

Other Information

do not use if blister unit is torn or open

Inactive Ingredients

FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene

glycol, purified water, sorbitol sorbitan solution, white edible ink

Description

Acetaminophen 325mg Dextromethorphan HBr 10mg Phenylephrine HCl 5mg

Principal Display Panel

Daytime Cold and Flu


Use(s)

temporarily relieves common cold and flu symptoms:    ■ nasal congestion   ■ cough due to minor throat and bronchial irritation   ■ sore throat   ■ headache   ■ minor aches and pains   ■ fever

Storage

store at room temperature 20-25 °C (68-77° F)

Questions

Call 1-888-952-0050 Monday through Friday

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 drugs. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Active Ingredient(s)

Acetaminophen 325mg

Dextromethorphan HBr 10mg

Phenylephrine HCl 5mg

Pregnancy/breastfeeding

ask a health professional before use.

When Using This Product

do not use more than directed

Ask A Doctor Before Use If

■ liver disease   ■ heart disease   ■ high blood pressure   ■ thyroid disease    ■ diabetes    ■ trouble urinating due to an enlarged prostate gland    ■ persistent or chronic cough such as occurs with smoking, asthma, or emphysema    ■ cough that occurs with too much phlegm (mucus)

Stop Use and Ask A Doctor If
  •  you get nervous, dizzy or sleepless
  • symptoms get worse or last more than 5 days (children) or 7 days (adults)
  • fever gets worse or lasts more than 3 days n redness or swelling is present
  • new symptoms occurs
  • cough comes back, or occurs with rash or headache that lasts. These could be signs of a serious condition.

Keep Out of Reach of Children

Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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 Or Pharmacist Before Use If

taking the blood thinning drug warfarin.


Structured Label Content

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 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, lasts for more than 2 days, occurs with or followed by fever,  headache, rash, nausea, or vomiting, see a doctor promptly.

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Directions

take only as directed

  • do not exceed 4 doses per 24 hours
  • Adults and children 12 years and over: 2 softgels with water every 4 hours
  • Children 4 to under 12 years: ask a doctor
  • Children under 4 years: do not use

Other Information (Other information)

do not use if blister unit is torn or open

Inactive Ingredients (Inactive ingredients)

FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene

glycol, purified water, sorbitol sorbitan solution, white edible ink

Principal Display Panel

Daytime Cold and Flu


Use(s)

temporarily relieves common cold and flu symptoms:    ■ nasal congestion   ■ cough due to minor throat and bronchial irritation   ■ sore throat   ■ headache   ■ minor aches and pains   ■ fever

Storage

store at room temperature 20-25 °C (68-77° F)

Questions

Call 1-888-952-0050 Monday through Friday

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 drugs. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Active Ingredient(s) (Active ingredient(s))

Acetaminophen 325mg

Dextromethorphan HBr 10mg

Phenylephrine HCl 5mg

Pregnancy/breastfeeding (Pregnancy/Breastfeeding)

ask a health professional before use.

When Using This Product (When using this product)

do not use more than directed

Ask A Doctor Before Use If (Ask a doctor before use if)

■ liver disease   ■ heart disease   ■ high blood pressure   ■ thyroid disease    ■ diabetes    ■ trouble urinating due to an enlarged prostate gland    ■ persistent or chronic cough such as occurs with smoking, asthma, or emphysema    ■ cough that occurs with too much phlegm (mucus)

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  •  you get nervous, dizzy or sleepless
  • symptoms get worse or last more than 5 days (children) or 7 days (adults)
  • fever gets worse or lasts more than 3 days n redness or swelling is present
  • new symptoms occurs
  • cough comes back, or occurs with rash or headache that lasts. These could be signs of a serious condition.

Keep Out of Reach of Children (Keep out of reach of children)

Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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 Or Pharmacist Before Use If (Ask a doctor or pharmacist before use if)

taking the blood thinning drug warfarin.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)