Otc - Purpose
Active ingredients (in each 30 mL) | Purposes |
| Acetaminophen 650 mg | Pain reliever/ fever reducer |
| Dextromethorphan HBr 20 mg | Cough suppressant |
Sanatos Liquid
FDA Label NDC 55758-415
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 55758-415). 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, warnings, do not use, ask a doctor before use if user, ask a doctor or pharmacist before use if the user is, stop use and ask a doctor if, if pregnant or breast-feeding,, 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 associted with
- minor aches & pains
- headache
- sore throat
- fever
- 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 6 doses in 24 hours, which is the maxium daily amount
- child takes more than 4 doses in 24 hours
- taken with other drugs containing acetaminophen
- adult has 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
- 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 User
- has a sodium restricted diet
- has liver disease
- hastrouble urinating due to enlarged prostate gland
- haspersistent or chronic cough such as occurs with smoking, asthma, or emphysema
- has a cough that occurs with too much phlegm (mucus)
- is a child with pain of arthritis
Ask A Doctor Or Pharmacist Before Use If The User Is
- taking the blood thinning drug warfarin
Stop Use And Ask A Doctor If
- pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
- 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 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
- use only dosing cup provided
- shake well before use
- if you are taking other cold/flu products, read complete labeling before dosing
| adults & children 12 years & over | 30 mL every 4 hours, do not exceed (child) 4 doses and (adult) 6 doses per 24 hours |
| children under 12 years of age | 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 anhydrous, FD&C yellow #6, flavor, glycerin, menthol, propylene glycol, sodium benzoate, sorbitol solution, sodium citrate, sucralose, xanthan gum, water
Questions?
+1-866-359-3478 (M-F) 9AM – 5PM EST or www.pharmadel.com
Distributed By:
Pharmadel LLC
New Castle, DE 19720
www.pharmadel.com
Facebook/PHARMADELUSA
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