FDA Label for Sanatos Nighttime Multi Symptoms
View Indications, Usage & Precautions
- 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
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- OVERDOSE WARNING:
- DIRECTIONS
- OTHER INFORMAITON
- INACTIVE INGREDIENTS
- QUESTIONS?
- DISTRIBUTED BY:
- PRINCPAL DISPLAY PANEL
Sanatos Nighttime Multi Symptoms Product Label
The following document was submitted to the FDA by the labeler of this product Pharmadel Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Purpose
Active ingredients (in each 30 mL dose cup) | Purposes |
Acetaminophen 650 mg..... | Pain reliever/ fever reducer |
Dextromethorphan HBr 30 mg..... | Cough suppressant |
Doxylamine succinate 12.5 mg..... | Antihistamine |
Uses
temporarily relieves these common cold/flu symptoms:
- sore throat
- headache
- minor aches and pains
- fever
- runny nose and sneezing
- cough due to minor throat and bronchial irritation
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks everyday while using this product
- skin reddening
- blisters
- rash
Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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 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.
- to make a child sleepy
Ask A Doctor Before Use If You Have
- a sodium-restricted diet
- liver disease
- glaucoma
- cough that occurs with too much phlegm (mucus)
- a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
- trouble urinating due to enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
When Using This Product
- do not use more than directed
- avoid alcoholic drinks
- excitability may occur, especially in children
- marked drowsiness may occur
- be careful when driving a motor vehicle or operating machinery
- alcohol, sedatives, and tranquilizers may increase drowsiness
Stop Use And Ask A Doctor If
- redness or swelling is present
- symptoms do not get better within 7 days or are accompanied by fever
- fever gets worse or lasts more than 3 days
- cough lasts more than 7 days, comes back, or occurs with fever, rash or headache that lasts
These could be signs of a serious condition.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Overdose Warning:
In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- take only as recommended - see Overdose warning
- use dose cup or tablespoon (TBSP)
- do not exceed 4 doses per 24 hours
- If taking Nighttime at night and Daytime during the day, limit total to 4 doses per 24 hours.
age | dose |
adults & children 12 years & over | 30 mL(2TBSP) every 6 hours |
children 4 to under 12 years | ask a doctor |
children under 4 years | do not use |
Other Informaiton
- each 30 mL dose cup contains: sodium 45 mg
- store at room temperature
Tamper Evident: Do not use if imprinted shrink band is missing or broken.
Inactive Ingredients
citric acid, D&C yellow#10, FD&C Green# 3, FD&C yellow# 6, flavor, glycerin, polythylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sucrose
Questions?
call 1-866-359-3478
Distributed By:
Pharmadel LLC
Seaford, DE 19973
www.sanatos.com
Princpal Display Panel
* Please review the disclaimer below.