Sanatos X Fast Action (ple)(apta)

SPL v2

SPL

SPL Set ID 85b8ef3d-7318-7f3b-e053-2991aa0a0777

Route

ORAL

Published

Effective Date 2018-12-03

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Dextromethorphan (20 mg) Acetaminophen (650 mg) Guaifenesin (400 mg) Phenylephrine (10 mg)

Inactive Ingredients

Anhydrous Citric Acid Edetic Acid Fd&c Blue No. 1 Propylene Glycol Propyl Gallate Sorbitol Sucralose Xanthan Gum Water Fd&c Red No. 40 Glycerin Sodium Benzoate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2018-12-03

Description

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

Medication Information

Description

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

Section 55105-1

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

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

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.

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.

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

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.

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.

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)

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.

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

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin

Structured Label Content

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

Section 55105-1 (55105-1)

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

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

Do Not Use (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.

Allergy Alert: (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.

Liver Warning: (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

Other Information (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 (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.

Sore Throat Warning: (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.

Questions Or Comments? (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)

Stop Use and Ask A Doctor If (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, (If pregnant or breastfeeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

Ask A Doctor Before Use If You Have (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

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking the blood thinning drug warfarin

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"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", "55105-1": "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", "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", "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.", "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.", "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", "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.", "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.", "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)", "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.", "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", "Ask a doctor or pharmacist before use if you are": "taking the blood thinning drug warfarin"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:20.775574 · Updated: 2026-03-14T23:01:50.647319