FDA Label for Sanatos X Children
View Indications, Usage & Precautions
- OTC - PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOUR CHILD IS
- ASK A DOCTOR BEFORE USE IF YOUR CHILD HAS
- WHEN USING THIS PRODUCT DO NOT EXCEED RECOMMENDED DOSAGE.
- STOP USE AND ASK A DOCTOR IF
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS
- PACKAGE PRINCIPAL DISPLAY PANEL
Sanatos X Children Product Label
The following document was submitted to the FDA by the labeler of this product Pharmadel Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Purpose
| 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
- skin reddening
- blisters
- rash
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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
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
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