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Sanatos (Pharmalab Enterprises Inc)

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LIQUID 177 mL in 1 BOTTLE, PLASTIC (14505-398-06) Label Information

Complete Sanatos 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

    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 yuo do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product


  • ASK DOCTOR

    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

    When using this product, do not use more than directed

  • STOP USE

    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.
  • 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 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.

  • INDICATIONS & USAGE

    Other information: each tablespoon contains sodium 50 mg

  • QUESTIONS

    Questions? (302) 725-0692

  • INGREDIENTS AND APPEARANCE
    SANATOS  DAY
    acetaminophen, dextromethorphan hydrobromide, phenylephrine liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:14505-398
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg  in 15 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg  in 15 mL
    PHENYLEPHRINE (UNII: 1WS297W6MV) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE 5 mg  in 15 mL
    Inactive Ingredients
    Ingredient Name Strength
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color yellow Score     
    Shape Size
    Flavor CHERRY (CHERRY) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:14505-398-06 177 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
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