FDA Label for Sanatos Multi Symptoms Nighttime
View Indications, Usage & Precautions
- OTC - PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF USER
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF USER IS
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMAITON
- INACTIVE INGREDIENTS
- QUESTIONS?
- DISTRIBUTED BY:
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Sanatos Multi Symptoms Nighttime 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) | Purposes |
Acetaminophen 650 mg | Pain reliever/ fever reducer |
Dextromethorphan HBr 30 mg | Cough suppressant |
Doxylamine succinate 12.5 mg | Antihistamine |
Uses
Temporarily relieves common cold/flu symptoms associated with
- minor aches and pains
- headache
- sore throat
- runny nose
- cough due to minor throat and bronchial irritation
- sneezing
- temoprarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- adults take more than 4 doses in 24 hours, which is the maxium daily amount
- child takes more than 3 doses in 24 hours
- taken with other drugs containing acetaminophen
- adult has 3 or more alcoholic drinks everyday 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 User
- has a sodium-restricted diet
- has liver disease
- has glaucoma
- has cough that occurs with too much phlegm (mucus)
- has a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
- has trouble urinating due to enlarged prostate gland
- is a child with pain of arthritis
Ask A Doctor Or Pharmacist Before Use If User Is
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When Using This Product
- excitability may occur, especially in children
- may cause marked drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect
- avoid alcoholic beverages
- use caution when driving a motor vehicle or operating machinery
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
- any 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
adults & children 12 years & over | 30 mL every 4 hours, do not exceed (child) 3 doses and (adult) 4 doses in 24 hours |
children under 12 years | ask a doctor |
Other Informaiton
- each 30 mL contains: sodium 10 mg
- store between 68-77°F (20-25°C)
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?
+1-866-359-3478 (M-F) 9AM – 5PM EST or www.pharmadel.com
Distributed By:
Pharmadel
New Castle, DE 19720
www.pharmadel.com
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