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  5. Label Information: Sanatos Night

FDA Label for Sanatos Night

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. WARNINGS
    4. OTC - DO NOT USE
    5. OTC - ASK DOCTOR
    6. OTC - WHEN USING
    7. OTC - STOP USE
    8. OTC - PREGNANCY OR BREAST FEEDING
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. OVERDOSAGE
    11. DOSAGE & ADMINISTRATION
    12. INDICATIONS & USAGE
    13. INACTIVE INGREDIENT
    14. OTC - QUESTIONS
    15. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sanatos Night Product Label

The following document was submitted to the FDA by the labeler of this product Pharmalab Enterprises Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient




Active Ingredients                               Purpose

(in each 15 mL tablespoon)

Acetaminophen 500mg........         Pain Reliever/Fever Reducer

Dextromethorphan HBr 15mg......    Cough Suppressant

Doxylamine succinate 6.25mg..................Antihistamine


Otc - Purpose



Uses: temporarily relieves common cold/flu symptoms:

  • Cough due to Minor Throat and Bronchial Irritation
  • Sore Throat
  • Headache
  • Minor Aches and Pains
  • Fever
  • runny nose and sneezing



Warnings



Warnings: Do not exceed recommended dosage.

Do not give to children under 12 years of age.

Liver Toxicity may occur if:

  • Recommended dosage is exceeded
  • Used with other products containing acetaminophen
  • Used with moderate amounts of alcohol
    • Alcohol Warning: If you consume 3 or more alcoholic drinks, ask your doctor whether you should take acetaminophen or other pain relievers. Acetaminophen may cause liver damage.
    Sore Throat Warning: If sore throat is severe, persists for more than two days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.



Otc - Do Not Use



Do not use 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 two 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



Otc - Ask Doctor



Stop Use and ask a doctor if you have:

  • Glaucoma
  • Trouble urinating due to enlarged prostate gland
  • Cough that occurs with too much phlegm(mucus)
  • Persistent or chronic cough as occurs with smoking, asthma or emphysema
  • Ask a doctor before use if you are taking sedatives or tranquilizers
    • Ask a doctor before use if you are taking sedatives or tranquilizers.



Otc - When Using



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

Otc - Stop Use




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
  • new symptoms occur
  • cough comes back, or occurs with rash or headache that lasts. This could be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding



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


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.


Overdosage



Overdose warning: Taking more than the recommended dose can cause serious health problems. 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.


Dosage & Administration



Directions: Take only as recommended. See Overdose Warning.

  • use dose cup or tablespoon(TBSP). Do not use more than 4 doses in 24 hours

    • Adults and children 12 years and older: Take 2 TBSP(30ml) every 6 hours, while symptoms persist or as directed by a doctor

    Children under 12 years of age: Consult a doctor. Do not use this adult extra strength product in children under 12 years of age. This will provide more than the recommended dose(overdose) of acetaminophen and cause serious problems.


Indications & Usage



Other information:

  • Store at controlled room temperature 15-30 C (59-86F)
  • each tablespoon contains: potassium 5 mg, sodium 18 mg. Contains 10% alcohol.

Inactive Ingredient





Otc - Questions



Questions? (302) 725-0692


Package Label.Principal Display Panel



SanaTosNightLabel - SanaTosNight

SanaTosNightLabel - SanaTosNight


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