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DAYTIME NIGHTTIME COLD/FLU (acetaminophen 325 mg dextromethorphan hydrobromide 15 mg doxylamine succinate 6.25 mg) Dailymed

  1. Human OTC
    • Drug Classes
  3. AGILE PHARMACHEM

Generic: acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl

DAYTIME NIGHTTIME COLD/FLU kit - (acetaminophen 325 mg dextromethorphan hydrobromide 15 mg doxylamine succinate 6.25 mg) image

IMPRINT: 512     SHAPE: capsule
    COLOR: orange

  1. FDA Adverse Reactions

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Active Ingredient


(in each softgel) of daytime cold and flu

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

(in each softgel) of nighttime cold and flu

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine Succinate 6.25 mg

Purpose


Daytime Cold and Flu:

pain reliever

Cough Suppressant

Nasal decongestant

Nighttime cold and flu purpose:

pain reliever

Cough Suppressant

Antihistamine

Uses


Daytime cold and flu: pain reliever, cough suppressant and Nasal decongestant

NightTime Cold and Flu: pain reliever, cough suppressant and Antihistamine

Warnings


Warnings Failure to follow these warnings could result in serious consequences.

Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take
  • more than 4 doses in 24 hours which is maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product
    do not use:
  • with any other drug containing acetaminophen (prescription or not prescription). 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.
    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
    ask your doctor or pharmacist before use if you are taking the blood thinning drug warfarin. When using this product, do not use more than directed.

    Stop use and ask a doctor if:
  • Redness or swelling is present
  • You get nervous, dizzy or sleepless
  • Fever gets worse or lasts more than 3 days
  • New symptoms occur
  • Symptoms do not get better within 7 days or are accompanied by a fever
    NightTime Cold and Flu: Warnings Failure to follow these warnings could result in serious consequences.

    Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take
  • more than 4 doses in 24 hours which is maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product

do not use:
  • with any other drug containing acetaminophen (prescription or not prescription). 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.

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

  • ask your doctor or pharmacist before use if you are taking the blood thinning drug warfarin. When using this product, do not use more than directed.

  • Stop use and ask a doctor if:
  • Redness or swelling is present
  • You get nervous, dizzy or sleepless
  • Fever gets worse or lasts more than 3 days
  • New symptoms occur
  • Symptoms do not get better within 7 days or are accompanied by a fever

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

Overdose warning: Taking more than recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Tamper evident: this package is safety sealed and child resistant. Use only if bulers are intact. If difficult to open use scissors.

Keep Out Of Reach Of Children.


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

Overdose warning: Taking more than recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Tamper evident: this package is safety sealed and child resistant. Use only if bulers are intact. If difficult to open use scissors.

Direction


Daytime Cold and Flu:
  • do not exceed 4 doses per 24 hours
  • take only as directed – see overdose warning
  • Adults and children 12 years and over: 2 softgels with water every 4 hours
  • children under 12 years: ask a doctor
  • Children under 4 years: do not use
    NightTime Cold and Flu
  • do not exceed 4 doses per 24 hours
  • take only as directed – see overdose warning
  • Adults and children 12 years and over: 2 softgels with water every 4 hours
  • children under 12 years: ask a doctor
  • Children under 4 years: do not use

Other Information

  • store at controlled temperature of 59°F to 86°F(15°C to 30°C)
  • Protect from direct sun light /Moisture/Freezing

Inactive Ingredients


Daytime:

FD&C Red No.40, FD&C Yellow No. 6, Gelatin, Glycerin, Poyethylene Glycol, Povidone, Propylene Glycol, Purified Water, Sorbitol Special, Titanium dioxide

NightTime:

FD&C Blue No.1, FD&C Yellow No. 6, Gelatin, Glycerin, Poyethylene Glycol, Povidone, Propylene Glycol, Purified Water, Sorbitol Special, Titanium dioxide, glycerin

Questions Or Comments


Call toll free 1-855-314-1850

Package Label.principal Display Panel






NDC: 58805-004-12   12 softgels, 8 DayTime Cold and Flu, 4 NightTime Cold and Flu

NDC: 58805-004-16   12 softgels, 8 DayTime Cold and Flu, 4 NightTime Cold and Flu

NDC: 58805-004-18   12 softgels, 8 DayTime Cold and Flu, 4 NightTime Cold and Flu

DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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