Drug Facts
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Sanatos Capsule, Liquid Filled
FDA Label NDC 55758-514
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pharmadel Llc for the product Sanatos (NDC 55758-514). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, active ingredients and purposes, active ingredients (in each softgel) purposes, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients And Purposes
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Active Ingredients (In Each Softgel) Purposes
Acetaminophen 325 mg ............................Pain reliever/ fever reducer
Dextromethorphan HBr 10 mg .................Cough suppressant
Phenylephrine HCI 5 mg ........................Nasal decongestant
Uses
Temporarily relieves the common cold/flu symptoms
- minor aches and pains
- sore throat
- headache
- stuffy nose
- nasal congestion
- cough due to minor throat and bronchial irritation
- temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 8 softgels in 24 hours, which is the maximum daily amount for this product
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
- skin reddening
- blisters
- rash If a skin reaction occurs, stop use and seek medical help right away.
Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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
- 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 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.
Ask A Doctor Before Use If You Have
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- a cough that is accompanied by excessive phlegm (mucus)
- a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
- trouble urinating due to an enlargeaad prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are
taking the blood thinning drug warfarin
When Using This Product
do not exceed recommended dosage
Stop Use And Ask A Doctor If
- nervousness, dizziness, or sleeplessness occur
- redness or swelling is present
- pain, nasal congestion or cough congestion gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- any new symptoms occur
- cough comes back or occurs with rash or headache that lasts. 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.
Directions
- if you are taking other cold/flu products, read complete labeling before dosing
| Age | Dose |
| adults and children 12 years and older | two (2) softgels every 6 hours, do not exceed 8 softgels in 24 hours |
| children 4 to under 12 years | ask a doctor |
| children under 4 years | do not use |
Other Information
- store between 68-77°F (20-25°C)
- avoid excess heat
Inactive Ingredients
FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide
Questions?
+1-866-359-3478 (M-F) 9 AM - 5 PM EST or www.pharmadel.com
Dist. By/ Por:
Pharmadel LLC
New Castle, DE 19947
+1-866-359-3478
†This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® Dayquil® Liquicap®
* Please review the disclaimer below.
