Sanatos Nighttime Relief Capsule, Liquid Filled
FDA Label NDC 55758-515

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pharmadel Llc for the product Sanatos Nighttime Relief (NDC 55758-515). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, active ingredients and purposes, purposes, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients And Purposes

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Purposes

Active ingredients(in each softgel) Purpose

Acetaminophen 325mg ...........................................................Pain reliever/ fever reducer

Dextromethorphan HBr 20mg....................................................Cough suppressant

Doxylamine succinate 12.5mg.................................................... Antihistamine

Uses

Temporarily relieves the common cold/flu symptoms associated with

  • minor aches and pains
  • headache
  • sore throat
  • runny nose
  • cough due to minor throat and bronchial irritation
  • sneezing
  • temporarily reduces fever

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
  • 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.

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.

Ask A Doctor Before Use If You Have

  • liver disease
  • glaucoma
  • a persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • a cough that is accompanied by excessive phlegm (mucus)
  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urination due to enlargement of the prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

When Using This Product

  • excitability may occur, especially in children
  • marked drowsiness may occur
  • alcoholic, sedatives, and tranquillizers may increase drowsiness
  • avoid alcoholic beverages
  • use caution when driving a motor vehicle or operating machinery

Stop Use And Ask A Doctor If

  • pain or cough gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • any 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.

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.

Directions

  • if you are taking other cold/flu products, read complete labeling before dosing
  • AgeDose
    adults and children 12 years and older two (2) softgels every 6 hours, do not exceed 8 softgels in 24 hours
    children 4 to under 12 years ask a doctor
    children under 4 yearsdo not use

Other Information

  • store between 68-77°F (20-25°C)
  • avoid excess heat

Inactive Ingredients

D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

Questions?

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

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