Target Daytime Nighttime Ultra Concentrated Cold And Flu Liquid Filled Capsules

Target Daytime Nighttime Ultra Concentrated Cold And Flu Liquid Filled Capsules
SPL v3
SPL
SPL Set ID 0c0cf76f-2dd3-45ef-e063-6394a90a9fef
Route
ORAL
Published
Effective Date 2023-09-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenylephrine (5 mg) Dextromethorphan (10 mg) Acetaminophen (325 mg) Doxylamine (6.25 mg)
Inactive Ingredients
Sorbitan Propylene Glycol Shellac Mica Fd&c Yellow No. 6 Aluminum Lake Polyethylene Glycol, Unspecified Povidone Water Titanium Dioxide Gelatin Sorbitol Glycerin D&c Yellow No. 10 Fd&c Blue No. 1

Identifiers & Packaging

Pill Appearance
Imprint: 152 Shape: oval Color: orange Color: green Size: 15 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-05-01

Description

Daytime Ultra Concentrated Cold & Flu

Purpose

Pain reliever/fever reducer Cough suppressant Nasal decongestant


Medication Information

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Description

Daytime Ultra Concentrated Cold & Flu

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 42229-5

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.

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.
Drug Facts

Daytime Ultra Concentrated Cold & Flu

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

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

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

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.

Questions Or Comments?

Call 1-800-910-6874

Principal Display Panel

When Using This Product

do not use more than directed

• excitability may occur, especially in children

• marked drowsiness may occur

• avoid alcoholic drinks

• be careful when driving a motor vehicle or operating machinery

• alcohol, sedatives, and tranquilizers may increase drowsiness

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.

Keep Out of Reach of Children.

Active Ingredient (in Each Softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

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
Ask A Doctor Or Pharmacist Before Use If You Are

• taking sedatives or tranquilizers

• taking the blood thinning drug warfarin

ask A Doctor Or Pharmacist Before Use If You Are 

taking the blood thinning drug warfarin

When Using This Product do Not Use More Than Directed


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 42229-5 (42229-5)

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.

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

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.
Drug Facts

Daytime Ultra Concentrated Cold & Flu

Allergy Alert: (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

Liver Warning: (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

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

Sore Throat Warning: (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.

Questions Or Comments? (Questions or comments?)

Call 1-800-910-6874

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

When Using This Product (When using this product)

do not use more than directed

• excitability may occur, especially in children

• marked drowsiness may occur

• avoid alcoholic drinks

• be careful when driving a motor vehicle or operating machinery

• alcohol, sedatives, and tranquilizers may increase drowsiness

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.

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

Active Ingredient (in Each Softgel) (Active ingredient (in each softgel))

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

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
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

• taking sedatives or tranquilizers

• taking the blood thinning drug warfarin

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

When Using This Product do Not Use More Than Directed (When using this product do not use more than directed)


Advanced Ingredient Data


Raw Label Data

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