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Sanatos

Pharmalab Enterprises Inc
Pharmalab Enterprises Inc

Drug Facts




FULL PRESCRIBING INFORMATION

Active ingredient


Active Ingredients                               Purpose

(in each 15 mL tablespoon)

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

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

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

Purpose

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
Sore Throat Warning


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 a sk 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.

Uses

Other information: each tablespoon contains sodium 50 mg


Questions? (302) 725-0692

Sanatos

Sanatos

Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:14505-398
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 325 mg
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 10 mg
PHENYLEPHRINE PHENYLEPHRINE 5 mg

Inactive Ingredients

Ingredient Name Strength
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

Color
yellow

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:14505-398-06 177 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2010-02-04


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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