(DA) SanaTos X Children (Apta)

SanaTos X Children by

Drug Labeling and Warnings

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

Drug Details [pdf]

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

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(DA) SanaTos X Children (Apta)

Drug Facts

Active ingredients & Purposes

• 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

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

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.

Ask a doctor or pharmacist before use if your child is

aking the blood thinning drug warfarin.

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

When using this product do not exceed recommended dosage.

• do not use more than directed

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

If pregnant or breast feeding,

ask a health professional before use.

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.

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

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

Questions

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

PACKAGE PRINCIPAL DISPLAY PANEL

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55758-437
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg  in 100 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 100 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg  in 100 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
XANTHAN GUM (UNII: TTV12P4NEE)
PROPYL GALLATE (UNII: 8D4SNN7V92)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Product Characteristics
Color	purple	Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55758-437-04	1 in 1 CARTON	08/01/2024	08/01/2024
1		118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	08/01/2024	08/01/2024

Labeler - Pharmadel LLC (030129680)

Revised: 8/2024

Document Id: 1fcfabf3-7c94-22ca-e063-6294a90a0b70

34390-5

Set id: 1dda06ac-c244-2272-e063-6394a90a6801

Version: 3

Effective Time: 20240816