Medication Guide App

Sanatos Day

Dosage form: liquid
Ingredients: ACETAMINOPHEN 325mg in 15mL, DEXTROMETHORPHAN HYDROBROMIDE 10mg in 15mL, PHENYLEPHRINE 5mg in 15mL
Labeler: Pharmalab Enterprises Inc
NDC Code: 14505-398

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 325m........         Pain Reliever/Fever Reducer

Dextromethorphan HBr 10mg......    Cough Suppressant

Phenylephrine HCl 5mg..................Nasal Decongestant

Uses: Temporarily relieves common cold/flu symptoms:

  • Nasal Congestion
  • Cough due to Minor Throat and Bronchial Irritation
  • Sore Throat
  • Headache
  • Minor Aches and Pains
  • Fever


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 yuo 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:

  • Heart Disease
  • Thyroid Disease
  • Diabetes
  • High Blood Pressure
  • 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


When using this product, do not use more than directed

Stop Use and ask a doctor if:

  • you get nervous, dizzy, or sleepless
  • symptoms get worse or lasts more than 5 days(children) or 7 days (adults)
  • 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 5 doses(children) or 6 doses(adults) in 24 hours

Adults and children 12 years and older: Take 2 TBSP(30ml) every 4 hours, while symptoms persist or as directed by a doctor
Children 6 to under 12 years of age: take 1 TBSP 15ml every 4 hours, while symptoms persist or as directed by a doctor
Children under 6 years of age: Consult a doctor. Do not use this adult extra strength product in children under 6 years of age. This will provide more than the recommended dose(overdose) of acetaminophen and cause serious problems.

Other information: each tablespoon contains sodium 50 mg


Questions? (302) 725-0692

SANATOS  DAY
acetaminophen, dextromethorphan hydrobromide, phenylephrine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14505-398
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg  in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 15 mL
PHENYLEPHRINE (PHENYLEPHRINE) PHENYLEPHRINE5 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE SODIUM 
CITRIC ACID MONOHYDRATE 
EDETATE DISODIUM 
FD&C YELLOW NO. 6 
GLYCERIN 
PROPYLENE GLYCOL 
WATER 
SACCHARIN SODIUM 
SODIUM BENZOATE 
SODIUM CHLORIDE 
SODIUM CITRATE 
SORBITOL 
SUCRALOSE 
Product Characteristics
ColoryellowScore    
ShapeSize
FlavorCHERRY (CHERRY) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:14505-398-06177 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

Revised: 09/2010
 
Pharmalab Enterprises Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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