Otc - Purpose
| Active ingredients (in each tablet) | Purposes |
| Acetaminophen 325 mg | Pain reliever/ fever reducer |
| Dextromethorphan HBr 15 mg | Cough suppressant |
| Guaifenesin 200 mg | Expectorant |
| Phenylephrine HCI 5 mg | Nasal decongestant |
Sanatos Multi Symptom Tablet
FDA Label NDC 55758-361
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 Multi Symptom (NDC 55758-361). 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 otc - purpose, uses, liver warning:, allergy alert:, sore throat warning:, 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
Uses
Temporarily relieves common cold/flu symptoms:
- minor aches & pains
- headache
- sore throat
- nasal congestion due to hay fever
- sinus congestion
- helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
- temporarily reduces fever
Liver Warning:
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 8 tablets 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
Allergy Alert:
Acetaminophen may cause severe skine reactions. Symptoms may include:
- skin reddening
- blisters
- rash
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 vomitting, consult a doctor promptly.
Do Not Use
- with any 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, asl a doctor or pharmacist before taking this product.
- for more than 7 days for pain and 3 days or fever, unless directed by a doctor.
Ask A Doctor Before Use If You Have
- liver disease
- heart disease
- high blood pressure
- throid disease
- diabetes
- trouble urinating due to enlarged prostate gland
- a cough that is accompained by excessive phlegm (mucus)
- a persistant or chronic cough such as occurs with smoking, asthma or emphysema
Ask A Doctor Or Pharmacist Before Use If You Are
- taking the blood thinning drug warfarin
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 recommended dosage
- adults and children 12 years of age and over:
- take 2 tablets every 6-8 hours; do not exceed 8 tablets in a 24-hour period
- children under 12 years of age: consult a doctor
Other Information
- store at room temperature 59-86F (15-30C)
- avoid excessive heat and humidity
TAMPER EVIDENCE: Do not use if packet is open or torn.
Inactive Ingredients
corn starch, microcrystalline cellulose, povidone-iodine, povidone k30, silicone dioxide, stearic acid, talc
Questions & Comments?
+1-866-359-3478 (M-F) 9AM to 5 PM EST or www.pharmadel.com
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