SANATOS X- acetaminophen, dextromethorphan hbr,guaifenesin, phenylephrine hci liquid 
Pharmadel LLC

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SanaTos X Fast Action (PLE)(APTA)

Drug Facts

Active ingredients and Purposes

Active ingredients (in each 20 mL)Purposes
Acetaminophen 650mg ......Pain reliever/fever reducer
Dextromethorphan HBr 20 mg .............Cough suppressant
Guaifenesin 400 mg .....................................Expectorant
Phenylephrine HCI 10 mg...................Nasal decongestant

Uses

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 or pharmacist before use if you are

taking the blood thinning drug warfarin

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.

If pregnant or breastfeeding,

ask a health professional before use.

Keep out of reach of children.

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

agedose
adults & children 12 years of age & over20 mL every 4 hours
children under 12 years of agedo not use

Other information

TAMPER EVIDENT FEATURE: Do not use if printed seal under cap is torn or missing.

Inactive ingredients

anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.

Questions or comments?

1-866-359-3478 (M-F) 9 AM to 5 PM EST or www.pharmadel.com

Principal Display Panel

MAXIMUM STRENGTH • MÁXIMA POTENCIA

SANATOS® X

FAST ACTION/ACCIÓN RÁPIDA

ACETAMINOPHEN Dextromethorphan HBr, Guaifenesin, Phenylephrine HCI/ACETAMINOFÉN Dextrometorfano HBr,
Guaifenesina, Fenilefrina HCl

COUGH, 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 Nasal

For ages 12+/Para edades 12+

6 fl oz (177 mL)

Santos X

SANATOS X 
acetaminophen, dextromethorphan hbr,guaifenesin, phenylephrine hci liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-311
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
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)  
WATER (UNII: 059QF0KO0R)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55758-311-061 in 1 BOX12/03/2018
11 in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01312/03/2018
Labeler - Pharmadel LLC (030129680)

Revised: 11/2023
Document Id: 0a1d578c-3260-6795-e063-6294a90a3142
Set id: 85b8ef3d-7318-7f3b-e053-2991aa0a0777
Version: 2
Effective Time: 20231114
 
Pharmadel LLC