NDC | 55758-311-06 |
Set ID | 85b8ef3d-7318-7f3b-e053-2991aa0a0777 |
Category | HUMAN OTC DRUG LABEL |
Packager | Pharmadel LLC |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- Drug Facts
- Active ingredients and Purposes
-
Uses
- temporarily relieves these common cold/ flu symptoms:
- minor aches and pains
- headache
- sore throat
- cough due to minor throat and bronchial irritation
- helps loosen phlegm (mucus) and thin bronchial
- secretions to drain bronchial tubes
- make coughs more productive
- nasal congestion
- stuffy nose
- hay fever
- temporarily reduces fever
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Warnings
Liver warning:
This product contains acetaminophen.
Severe liver damage may occur if you:- take more than 6 doses in 24 hours, which is the maximum daily amount
- take with other drugs containing acetaminophen
- have 3 or more alcoholic drinks every day while using this product
Allergy alert:
Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash If an allergic reaction occurs, stop use and seek medical help right away.
Sore throat warning:
Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult physician promptly.
Do not use
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if you or your child are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child’s or your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
- liver disease
- high blood pressure
- a cough that is accompanied with excessive phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, bronchitis, or emphysema
- diffculty in urination due to enlargement of the prostate gland
- heart disease
- thyroid disease
- diabetes
Stop use and ask a doctor if
- skin rash appears
- symptoms persist for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache.
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- nervousness, dizziness, or sleeplessness occur
These could be signs of a serious condition.
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel
MAXIMUM STRENGTH • MÁXIMA POTENCIA
SANATOS® X
FAST ACTION/ACCIÓN RÁPIDA
ACETAMINOPHEN Dextromethorphan HBr, Guaifenesin, Phenylephrine HCI/ACETAMINOFÉN Dextrometorfano HBr,
Guaifenesina, Fenilefrina HClCOUGH, COLD & SORE THROAT/TOS, RESFRIADO y DOLOR DE GARGANTA
Fever/Fiebre
Aches and pains/Dolores y molestias leves
Headache/Dolor de Cabeza
Expectorant/Expectorante
Nasal decongestant/Descongestivo NasalFor ages 12+/Para edades 12+
6 fl oz (177 mL)
-
INGREDIENTS AND APPEARANCE
SANATOS X
acetaminophen, dextromethorphan hbr,guaifenesin, phenylephrine hci liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55758-311 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 400 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) EDETATE DISODIUM (UNII: 7FLD91C86K) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYL GALLATE (UNII: 8D4SNN7V92) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55758-311-06 1 in 1 BOX 12/03/2018 1 1 in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 12/03/2018 Labeler - Pharmadel LLC (030129680)