Target -695t Combo Day-night Cold And Flu Relief

Target -695t Combo Day-night Cold And Flu Relief
SPL v4
SPL
SPL Set ID 9def204a-ee1e-6868-e053-2995a90a76b8
Route
ORAL
Published
Effective Date 2025-01-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (10 mg) Acetaminophen (325 mg) Phenylephrine (5 mg) Doxylamine (15 mg)
Inactive Ingredients
Fd&c Red No. 40 Glycerin Water Shellac Polyethylene Glycol, Unspecified Propylene Glycol Titanium Dioxide Sorbitol Povidone Gelatin Fd&c Yellow No. 6 Fd&c Blue No. 1 D&c Yellow No. 10

Identifiers & Packaging

Pill Appearance
Imprint: 71 Shape: capsule Color: orange Color: green Size: 20 mm Size: 21 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-07-08

Description

DRUG FACTS


Medication Information

Warnings and Precautions

Warnings

Liver warning
- This product contains acetaminophen. Severe liver damage may occur if you take - more than 8 softgels in 24 hrs, which is the maximum daily amount for this product

Severe liver damage may occur if you take:

  • more than 8 softgels in 24 hrs, 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.

Indications and Usage

Uses

temporarily relieves common cold/flu symptoms:

  • nasal congestion
  • cough due to minor throat & bronchial irritation
  • sore throat
  • headache
  • minor aches & pains
  • fever
Dosage and Administration

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

Description

DRUG FACTS

Section 50565-1

Keep out of reach of children.

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 & for children even if you do not notice any signs or symptoms.

Section 50566-9

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.

Section 50567-7

When using this product, do not use more than directed.

Section 50568-5

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

Section 50569-3

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
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 51727-6

Inactive ingredients FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide.

Section 51945-4

Section 53413-1

Questions or comments? Call 1-877-290-4008

Section 53414-9

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

Section 55105-1

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Section 55106-9

Active ingredients (in each softgels)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Section 60561-8

Other information

  • store at room temperature
Nighttime Cold and Flu

DRUG FACTS

Daytime Cold and Flu Reliefdrug Facts

DRUG FACTS


Structured Label Content

Indications and Usage (34067-9)

Uses

temporarily relieves common cold/flu symptoms:

  • nasal congestion
  • cough due to minor throat & bronchial irritation
  • sore throat
  • headache
  • minor aches & pains
  • fever
Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

Warnings

Liver warning
- This product contains acetaminophen. Severe liver damage may occur if you take - more than 8 softgels in 24 hrs, which is the maximum daily amount for this product

Severe liver damage may occur if you take:

  • more than 8 softgels in 24 hrs, 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.

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 (1-800-222-1222). Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

Section 50566-9 (50566-9)

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.

Section 50567-7 (50567-7)

When using this product, do not use more than directed.

Section 50568-5 (50568-5)

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

Section 50569-3 (50569-3)

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
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 51727-6 (51727-6)

Inactive ingredients FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments? Call 1-877-290-4008

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Section 55106-9 (55106-9)

Active ingredients (in each softgels)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Section 60561-8 (60561-8)

Other information

  • store at room temperature
Nighttime Cold and Flu (NIGHTTIME COLD AND FLU)

DRUG FACTS

Daytime Cold and Flu Reliefdrug Facts (DAYTIME COLD AND FLU RELIEFDRUG FACTS)

DRUG FACTS


Advanced Ingredient Data


Raw Label Data

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