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

SanaTos X by

Drug Labeling and Warnings

SanaTos X by is a Otc medication manufactured, distributed, or labeled by Pharmadel LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• 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

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

• 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)

INGREDIENTS AND APPEARANCE

SANATOS X 
acetaminophen, dextromethorphan hbr,guaifenesin, phenylephrine hci liquid

Product 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)