Target Daytime Ultra Concentrated Cold And Flu Softgels

Target Daytime Ultra Concentrated Cold And Flu Softgels
SPL v1
SPL
SPL Set ID 1bc90b2f-612c-e977-e063-6294a90a40b4
Route
ORAL
Published
Effective Date 2024-06-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenylephrine (5 mg) Acetaminophen (325 mg) Dextromethorphan (10 mg)
Inactive Ingredients
Shellac Glycerin Sorbitan Gelatin Mica Propylene Glycol Water Povidone Sorbitol Solution Polyethylene Glycol 400 Titanium Dioxide Fd&c Yellow No. 6 Aluminum Lake

Identifiers & Packaging

Pill Appearance
Imprint: 151 Shape: oval Color: orange Size: 15 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-30

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer Cough suppressant Nasal decongestant


Medication Information

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg

Uses

temporarily relieves common cold/flu symptoms:

  • nasal congestion
  • cough due to minor throat & bronchial irritation
  • sore throat
  • headache
  • minor aches & pains
  • fever
Section 34088-5

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 51945-4

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 8 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.

Directions
  • take only as directed
  • do not exceed 8 softgels per 24 hrs

    adults & children 12 yrs & over

    2 softgels with water every 4 hrs

    children 4 to under 12 yrs

    ask a doctor

    children under 4 yrs

    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.
Other Information
  • store at no greater than 25°C
Inactive Ingredients

FD&C yellow no. 6 Al. lake, gelatin, glycerin, mica, polyethylene glycol 400, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide

Questions Or Comments?

Call 1-800-910-6874

Stop Use and Ask A Doctor If
  • you get nervous, dizzy or sleepless
  • pain, nasal congestion, or cough 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.

If Pregnant Or Breast Feeding,

ask a health professional before use.

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

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin.


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
Section 34088-5 (34088-5)

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 51945-4 (51945-4)

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 8 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.

Directions
  • take only as directed
  • do not exceed 8 softgels per 24 hrs

    adults & children 12 yrs & over

    2 softgels with water every 4 hrs

    children 4 to under 12 yrs

    ask a doctor

    children under 4 yrs

    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.
Other Information (Other information)
  • store at no greater than 25°C
Inactive Ingredients (Inactive ingredients)

FD&C yellow no. 6 Al. lake, gelatin, glycerin, mica, polyethylene glycol 400, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide

Questions Or Comments? (Questions or comments?)

Call 1-800-910-6874

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 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.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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
  • trouble urinating due to enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • 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

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

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.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)