SANATOS NIGHT- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate liquid

Sanatos by

Drug Labeling and Warnings

Sanatos by is a Otc medication manufactured, distributed, or labeled by Pharmalab Enterprises Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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.

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

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.

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

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.

PREGNANCY OR BREAST FEEDING

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

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

QUESTIONS

Questions? (302) 725-0692

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SANATOS  NIGHT
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14505-399
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg  in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg  in 15 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	6.25 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	green	Score
Shape		Size
Flavor	ANISE (ANISE)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14505-399-06	177 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	02/04/2010

Labeler - Pharmalab Enterprises Inc (174401088)

Registrant - Pharmalab Enterprises Inc (174401088)

Establishment
Name	Address	ID/FEI	Business Operations
Pharmalab Enterprises Inc		174401088	manufacture