Drug Facts
Drug Facts
Sanatos Granule, For Solution
FDA Label NDC 55758-384
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 55758-384). 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, otc - purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active ingredients (in each packet) | Purposes |
| Acetaminophen 650 mg | Pain reliever/ fever reducer |
| Dextromethorphan HBr 20 mg | Cough suppressant |
| Phenylephrine HCI 10 mg | Nasal decongestant |
Uses
Temporarily relieves common cold/flu symptoms:
- minor aches & pains
- sore throat
- headache
- nasal congestion
- cough due to minor throat & bronchial irritation
- and temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 6 packets in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
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 as occurs with smoking, asthma, chronic bronchitis, or emphysema
- difficulty urinating due to enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are
- taking the blood thinning drug warafin
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 or nasal congestion gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- any new symptoms occur
If Pregnant Or Breast-Feeding,
ask a health care 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
- dissolve one packet in an 8oz. glass of hot water. If using a microwave; add content into a glass of cool water and stir briskly before and after heating. Do not overheat.
- sip while hot and consume the entire drink within 10-15 minutes
- adults & children 12 years of age and over: one (1) packet every 4 hours, do not exceed 6 packets per 24 hours
- children under 12 years of age: do not use
Other Information
- each packet contains: potassium 10 mg, sodium 27 mg
- phenylketonurics: contains phenylalanine 13 mg per packet
- store at room temperature 68-77°F (20-25°C)
- do not use if packets are punctured or torn.
Inactive Ingredients
acesulfame potassium, anhydrous citric acid, aspartame, chamomile berry flavors, FD&C blue 1, FD&C red 40, isopropyl alcohol, maltodextrin, silicon dioxide, sodium citrate, sucrose, tribasic calcium phosphate, water
Questions?
+1-866-359-3478 (M-F) 9 AM to 5 PM EST or www.pharmadel.com
Distributed By:
PHARMADEL LLC
New Castle, DE 19270
Made in India
* Please review the disclaimer below.
