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Sanatos (sanatos daytime (acetaminophen, dextromethorphan, phenylephrine) capsule, liquid filled) Dailymed



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Drug Facts


Active Ingredients And Purposes


OTC - PURPOSE SECTION

Active ingredients (in each softgel) Purposes
Acetaminophen 325 mg .................... Pain reliever/ fever reducer
Dextromethorphan HBr 10 mg .........
Cough suppressant
Phenylephrine HCl 5 mg ..................
Nasal decongestant

Uses


Temporarily relieves common cold/flu symptoms
  • headache
  • minor aches and pains
  • nasal congestion due to hay fever or other upper respiratory allergies
  • sinus congestion and pressure
  • and reduces fever

Warnings


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

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
  • skin reddening
  • bulers
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

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.
  • for more than 3 days for fever unless directed by a doctor

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • a cough that is accompanied by excessive phlegm (mucus)
  • a persistent or chronic cough as occurs with smoking, asthma, or emphysema
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin

Stop use and ask a doctor if

  • symptoms do not improve within 7 days, tend to recur, or are accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
  • new symptoms occur
  • redness or swelling is present
  • nervousness, dizziness, or sleeplessness occur

If pregnant or breast-feeding,


ask a health professional before use.

Keep out of reach of children.


In case of accidental 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.

Directions

  • do not exceed recommended dosage (see Liver warning)
  • do not exceed 4 doses in a 24 hour period
Age
Dose
adults and children 12 years and older 2 softgels every 6 hours
children 4 to under 12 years consult a doctor
children under 4 years do not use

Other Information

  • store between 68-77°F (20-25°C)
  • avoid excessive heat
  • do not use if buler pack unit is punctured or torn

Inactive Ingredients


FD&C red #40, FD&C yellow #6, gelatin, glycerin, methylparaben, polyethylene glycol 400, povidone k-30, propylene glycol, propylparaben, sorbitol, titanium dioxide, water.

Questions Or Comments?


+1-866-359-3478 (M-F) 9 AM - 5 PM EST or www.pharmadel.com

Distributed By:


Distributed by:

PHARMADEL LLC

New Castle, DE, 19720

/PHARMADELUSA

Principal Display Panel




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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