FDA Label for Sanatos Multi Symptom Daytime
View Indications, Usage & Precautions
Sanatos Multi Symptom Daytime 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 ingredients (in each 15 mL, 1 tablespoon) | Purposes |
Acetaminophen 325 mg | Pain reliever/fever reducer |
Dextromethorphan HBr 10 mg | Cough suppressant |
Phenylephrine HCI 5 mg | Nasal decongestant |
Uses
temporarily relieves common cold/flu symptoms:
- minor aches & pains
- headache
- sore throat
- fever
- nasal congestion
- cough due to minor throat and bronchial irritation
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if
- adults take more than 4,000 mg if acetaminophen in 24 hours
- child take more than 5 doses in 24 hours
- taken with other drugs containing acetaminophen
- adult has 3 or more alcoholic drinks every day while using this product
- 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, rash, nausea, or vomiting, consult a doctor promptly.
Do Not Use
- if you 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Ask A Doctor Before Use If You Have
- liver disease
- heart disease
- thyroid disease
- diabetes
- high blood pressure
- trouble urinating due to enlarged prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- cough that occurs with too much phlegm (mucus)
When Using This Product
- do not use more than directed (see overdose warning)
- avoid alcoholic drinks
Stop Use And Ask A Doctor If
- you get nervos, dizzy or sleepless
- new symptoms occur
- fever gets worse or lasts more than 3 days
- pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
- redness or swelling is present
- cough comes back or occurs with rash or headache that lasts
These could be signs of a serious condition.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Overdose Warning:
In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- take only as recommended (see overdose warning)
- use a dosage cup or tablespoon (TBSP)
- do not exceed 4 doses per 24 hrs
- when using daytime and nighttime products, carefully read each label to ensure correct dosing.
age | dose |
adults & children 12 years & over | 30 mL (2 TBSP) every 4 hours |
children 6 years to under 12 years | 15 mL (1 b TBSP) every 4 hours |
children 4 years to under 6 years | ask a doctor |
children under 4 years | do not use |
Other Information
- sodium content per tablespoon: 10 mg
- store at room temperature
TAMPER EVIDENT: Do not use if imprinted band is missing or broken.
Inactive Ingredients
citric acid, FD&C yellow #6, flavor, glycerin, propylene glycol, purfied water, saccarhin sodium, sodium benzoate, sucrose
Questions?
call 1-866-359-3478
Distributed By:
Pharmadel LLC
Seaford, DE 19973
www.sanatos.com
* Please review the disclaimer below.