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Sanatos Night

Medically reviewed on September 11, 2017

Dosage form: liquid
Ingredients: ACETAMINOPHEN 500mg in 15mL, DEXTROMETHORPHAN HYDROBROMIDE 15mg in 15mL, DOXYLAMINE SUCCINATE 6.25mg in 15mL
Labeler: Pharmalab Enterprises Inc
NDC Code: 14505-399

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts


Active Ingredients                               Purpose

(in each 15 mL tablespoon)

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

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

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

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: 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.


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


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.


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


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.

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

Keep out of reach of children.

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.

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.

Other information:

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


Questions? (302) 725-0692

SANATOS  NIGHT
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14505-399
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg  in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 15 mL
DOXYLAMINE SUCCINATE (DOXYLAMINE ) DOXYLAMINE SUCCINATE6.25 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
FD&C YELLOW NO. 6 
PROPYLENE GLYCOL 
WATER 
SACCHARIN SODIUM 
SODIUM CHLORIDE 
SODIUM CITRATE 
ALCOHOL 
D&C YELLOW NO. 10 
FD&C GREEN NO. 3 
HIGH FRUCTOSE CORN SYRUP 
PROPYLENE GLYCOL 
Product Characteristics
ColorgreenScore    
ShapeSize
FlavorANISE (ANISE) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:14505-399-06177 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/04/2010
Labeler - Pharmalab Enterprises Inc (174401088)
Registrant - Pharmalab Enterprises Inc (174401088)
Establishment
NameAddressID/FEIOperations
Pharmalab Enterprises Inc174401088manufacture

 
Pharmalab Enterprises Inc

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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