Sanatos X Children (apta)

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (325 mg) Dextromethorphan (10 mg) Guaifenesin (200 mg) Phenylephrine (5 mg)

Inactive Ingredients

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

Identifiers & Packaging

Pill Appearance

Color: purple

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-08-01

Medication Information

Description

Active ingredient (in each 10 mL) Purposes Acetaminophen 325 mg ..................................... Pain reliever/ fever reducer Dextromethorphan HBr 10 mg............................... Cough suppressant Guaifenesin 200 mg............................................... Expectorant Phenylephrine HCI 5 mg........................................ Nasal decongestant

Uses

temporarily relieves these common cold/ flu symptoms:
nasal congestion
headache
sore throat
minor aches and pains
cough due to minor throat and bronchial irritation
temporarily reduces fever
helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Section 55105-1

Active ingredient (in each 10 mL)	Purposes
Acetaminophen 325 mg .....................................	Pain reliever/ fever reducer
Dextromethorphan HBr 10 mg...............................	Cough suppressant
Guaifenesin 200 mg...............................................	Expectorant
Phenylephrine HCI 5 mg........................................	Nasal decongestant

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes

more than 5 doses in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

skin reddening
blisters
rash

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, nausea, and vomiting, consult doctor promptly

Questions

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

Directions

this product does not contain directions or complete warnings for adult use
do not give more than directed (see Overdose warning)
shake well before use
children 6 to under 12 years of age: take 10 mL in dosing cup provided every 4 hours, while symptoms persist, up to 5 times a day or as directed by a doctor
children under 6 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.
in a child who is 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking product.

Other Information

each 10 mL contains: sodium 5 mg
store between 59-86°F (15-30°C)
do not refrigerate

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

Stop Use and Ask A Doctor If

pain, cough, or nasal congestion gets worse or lasts more than 5 days
fever gets worse or lasts more than 3 days
redness or swelling is present
new symptoms occur
nervousness, dizziness, or sleeplessness occur

Keep Out of Reach of Children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical even if you do not notice any signs or symptoms.

Package Principal Display Panel

Ask A Doctor Before Use If Your Child Has

liver disease
a cough that is accompanied with excessive phlegm (mucus)
a persistent or chronic cough such as occurs with asthma
heart disease
high blood pressure
thyroid disease
diabetes

Ask A Doctor Or Pharmacist Before Use If Your Child Is

aking the blood thinning drug warfarin.

When Using This Product Do Not Exceed Recommended Dosage.

do not use more than directed

Structured Label Content

Uses

temporarily relieves these common cold/ flu symptoms:
nasal congestion
headache
sore throat
minor aches and pains
cough due to minor throat and bronchial irritation
temporarily reduces fever
helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Section 55105-1 (55105-1)

Active ingredient (in each 10 mL)	Purposes
Acetaminophen 325 mg .....................................	Pain reliever/ fever reducer
Dextromethorphan HBr 10 mg...............................	Cough suppressant
Guaifenesin 200 mg...............................................	Expectorant
Phenylephrine HCI 5 mg........................................	Nasal decongestant

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes

more than 5 doses in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

skin reddening
blisters
rash

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, nausea, and vomiting, consult doctor promptly

Questions

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

Directions

this product does not contain directions or complete warnings for adult use
do not give more than directed (see Overdose warning)
shake well before use
children 6 to under 12 years of age: take 10 mL in dosing cup provided every 4 hours, while symptoms persist, up to 5 times a day or as directed by a doctor
children under 6 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.
in a child who is 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking product.

Other Information (Other information)

each 10 mL contains: sodium 5 mg
store between 59-86°F (15-30°C)
do not refrigerate

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

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

pain, cough, or nasal congestion gets worse or lasts more than 5 days
fever gets worse or lasts more than 3 days
redness or swelling is present
new symptoms occur
nervousness, dizziness, or sleeplessness occur

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

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical even if you do not notice any signs or symptoms.

Package Principal Display Panel (PACKAGE PRINCIPAL DISPLAY PANEL)

Ask A Doctor Before Use If Your Child Has (Ask a doctor before use if your child has)

liver disease
a cough that is accompanied with excessive phlegm (mucus)
a persistent or chronic cough such as occurs with asthma
heart disease
high blood pressure
thyroid disease
diabetes

Ask A Doctor Or Pharmacist Before Use If Your Child Is (Ask a doctor or pharmacist before use if your child is)

aking the blood thinning drug warfarin.

When Using This Product Do Not Exceed Recommended Dosage. (When using this product do not exceed recommended dosage.)

do not use more than directed

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

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