day time cold & flu multi-symptom relief

day time cold & flu multi-symptom relief
SPL v5
SPL
SPL Set ID d642c0b0-baa0-4c3e-8b1d-cfe3b73382da
Route
oral
Published
Effective Date 2021-04-28
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 yellow no. 6 fd&c red no. 40 gelatin glycerin polyethylene glycol 400 povidone k30 propylene glycol water sorbitol titanium dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 512;A09 Shape: capsule Color: red Size: 21 mm Score: 1
Marketing Status
otc monograph drug active Since 2021-04-28

Description

Drug Facts


Medication Information

Uses

temporarily relieves common cold/flu symptoms:

  • nasal congestion
  • cough due to minor throat & bronchial irritation
  • sore throat
  • headache
  • minor aches/pains
  • fever
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 4 hours
children 4 to under 12 years of age ask a doctor
children under 4 years of age do not use

If taking Daytime and Nighttime 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
Inactive Ingredients

FD&C Red No. 40, FD&C Yellow No.6. gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide

Description

Drug Facts

Principal Display Panel

non-drowsy daytime



Cold & Flu



Acetaminophen - Pain Reliever / Fever Reducer

Dextromethorphan HBr - Cough Suppressant

Phenylephrine HCl - Nasal Decongestant



Relief of:

• Headache • Fever • Sore Throat • Minor Aches & Pains

• Nasal Congestion • Sinus Pressure • Cough



Multi-symptom



10 Softgels

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50568-5

Ask a doctor or pharmacist before use if you are taking the blood-thinning drug Warfarin.

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.
Section 53414-9

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

Section 55105-1
Active ingredients (in each softgel) Purpose
Acetaminophen 325 mg Pain reliever/fever reducer
Dextromethorphan Hydrobromide 10 mg Cough suppressant
Phenylephrine HCl 5 mg Nasal decongestant
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
Allergy Alert:

acetaminophen may cause severe skin reactions. Symptoms may include: 

  • skin reddening
  • blisters
  • rash
Overdose Warning

Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults and for children, even if you do not notice any signs or symptoms.

Sore Throat Warning:

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

Questions Or Comments?

1-888-333-9792

When Using This Product
  • do not use more than directed.
Stop Use and Ask A Doctor If
  • you get nervous, dizzy, or sleepless
  • pain, nasal congestion or cough gets worse or last 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.

Ask A Doctor Before Use If You Have
  • liver disease
  • heart disease
  • thyroid disease
  • diabetes
  • high blood pressure
  • trouble urinating due to enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough as occurs with smoking, asthma, or emphysema

Structured Label Content

Uses

temporarily relieves common cold/flu symptoms:

  • nasal congestion
  • cough due to minor throat & bronchial irritation
  • sore throat
  • headache
  • minor aches/pains
  • fever
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 4 hours
children 4 to under 12 years of age ask a doctor
children under 4 years of age do not use

If taking Daytime and Nighttime 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
Inactive Ingredients (Inactive ingredients)

FD&C Red No. 40, FD&C Yellow No.6. gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

non-drowsy daytime



Cold & Flu



Acetaminophen - Pain Reliever / Fever Reducer

Dextromethorphan HBr - Cough Suppressant

Phenylephrine HCl - Nasal Decongestant



Relief of:

• Headache • Fever • Sore Throat • Minor Aches & Pains

• Nasal Congestion • Sinus Pressure • Cough



Multi-symptom



10 Softgels

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking the blood-thinning drug Warfarin.

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.
Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)
Active ingredients (in each softgel) Purpose
Acetaminophen 325 mg Pain reliever/fever reducer
Dextromethorphan Hydrobromide 10 mg Cough suppressant
Phenylephrine HCl 5 mg Nasal decongestant
Liver Warning (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
Allergy Alert: (Allergy alert:)

acetaminophen may cause severe skin reactions. Symptoms may include: 

  • skin reddening
  • blisters
  • rash
Overdose Warning (Overdose warning)

Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults and for children, even if you do not notice any signs or symptoms.

Sore Throat Warning: (Sore throat warning:)

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

Questions Or Comments? (Questions or comments?)

1-888-333-9792

When Using This Product (When using this product)
  • do not use more than directed.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you get nervous, dizzy, or sleepless
  • pain, nasal congestion or cough gets worse or last 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.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • liver disease
  • heart disease
  • thyroid disease
  • diabetes
  • high blood pressure
  • trouble urinating due to enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough as occurs with smoking, asthma, or emphysema

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)