SANATOS NIGHT- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate liquid 
Pharmalab Enterprises Inc

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.

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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:


Warnings: Do not exceed recommended dosage.

Do not give to children under 12 years of age.


Liver Toxicity may occur if:

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:


Stop Use and ask a doctor if you have:

Ask a doctor before use if you are taking sedatives or tranquilizers.


When using this product, do not use more than directed


Stop Use and ask a doctor if:

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.

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:


Questions? (302) 725-0692

SanaTosNightLabel

SANATOS  NIGHT
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14505-399
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg  in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 15 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
ALCOHOL (UNII: 3K9958V90M)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Product Characteristics
ColorgreenScore    
ShapeSize
FlavorANISE (ANISE) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
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/FEIBusiness Operations
Pharmalab Enterprises Inc174401088manufacture

Revised: 9/2010
Document Id: af1e5459-2fd9-4c0f-af63-bea42e73c14d
Set id: 8816ec3c-2a26-4bd5-9ba6-8f7fce999470
Version: 2
Effective Time: 20100909
 
Pharmalab Enterprises Inc