Drug Facts
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Sanatos Capsule, Liquid Filled
FDA Label NDC 55758-508
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 55758-508). 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, otc - purpose, uses, warnings, do not use, ask a doctor before use if you have, when using this product, 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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Otc - Purpose
| Active ingredients (in each softgel) | Purposes |
| Acetaminophen 325 mg .................... | Pain reliever/ fever reducer |
| Dextromethorphan HBr 10 mg ......... | Cough suppressant |
| Phenylephrine HCl 5 mg .................. | Nasal decongestant |
Uses
Temporarily relieves cough-cold symptoms
- cough due to minor throat and bronchial irritation
- headache
- minor aches and pains
- nasal congestion
- sinus congestion and pressure
- stuffy nose
- 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
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily while using this product
- skin reddening
- blisters
- rash.
Allergy alert: Acetaminophenmay cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
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 as occurs with smoking, asthma or emphysema
- difficulty urinating due to enlargement of the prostate gland
When Using This Product
do not exceed recommended dosage
Ask A Doctor Or Pharmacist Before Use If You Are
- taking the blood thinning drug warfarin
Stop Use And Ask A Doctor If
- nervousness, dizziness, or sleeplessness occur
- pain, cough or nasal congestions gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- 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 Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
In case of accidental 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
- do not exceed 4 doses in a 24 hour period
| Age | Dose |
| adults and children 12 years and older | 2 softgels every 4 hours, do not exceed 6 doses in a 24 hour period |
| children 4 to under 12 years | consult a doctor |
| children under 4 years | do not use |
Other Information
- store between 68-77°F (20-25°C)
- avoid excessive heat
- do not use if blister pack unit is punctured or torn
Inactive Ingredients
FD&C red #40, FD&C yellow #6, gelatin, glycerol, polyethylene glycol 400, povidone k30, propylene glycol, sorbitol sorbitan solution, water
Questions Or Comments?
+1-866-359-3478(M-F) 9 AM - 5 PM EST or www.pharmadel.com
Dist By/ Por:
PHARMADEL LLC
New Castle, DE 19720
www.pharmadel.com
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