FDA Label for Sanatos X

Otc - Purpose

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

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

• do not take more than directed
• dosing cup included
• do not take more than 6 doses in any 24-hour period
• this product is not intended for use in children under 12 years of age

age	dose
adults & children 12 years of age & over	20 mL every 4 hours
children under 12 years of age	do not use

Other Information

• each 20 mL contains: sodium 10 mg
• store at 59-86°F (15-30°C)
• do not refrigerate

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)