FDA Label for Sanatos Daytime
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
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- DISTRIBUTED BY:
- PRINCIPAL DISPLAY PANEL
Sanatos Daytime 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 softgel) | Purposes |
| Acetaminophen 325 mg .................... | Pain reliever/ fever reducer |
| Dextromethorphan HBr 10 mg ......... | Cough suppressant |
| Phenylephrine HCl 5 mg .................. | Nasal decongestant |
Uses
Temporarily relieves common cold/flu symptoms
- headache
- minor aches and pains
- nasal congestion due to hay fever or other upper respiratory allergies
- sinus congestion and pressure
- and reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4 doses in 24 hrs, which is the maximum daily amount for this product
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily 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.
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.
- for more than 3 days for fever unless directed by a doctor
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, or emphysema
- trouble urinating due to an enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are
- taking the blood thinning drug warfarin
Stop Use And Ask A Doctor If
- symptoms do not improve within 7 days, tend to recur, or are accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
- new symptoms occur
- redness or swelling is present
- nervousness, dizziness, or sleeplessness occur
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 (see Liver warning)
- do not exceed 4 doses in a 24 hour period
| Age | Dose |
| adults and children 12 years and older | 2 softgels every 6 hours |
| children 4 to under 12 years | consult a doctor |
| children under 4 years | do not use |
Other Information
- store between 68-77°F (20-25°C)
- avoid excessive heat
- do not use if blister pack unit is punctured or torn
Inactive Ingredients
FD&C red #40, FD&C yellow #6, gelatin, glycerin, methylparaben, polyethylene glycol 400, povidone k-30, propylene glycol, propylparaben, sorbitol, titanium dioxide, water.
Questions Or Comments?
+1-866-359-3478 (M-F) 9 AM - 5 PM EST or www.pharmadel.com
Distributed By:
Distributed by:
PHARMADEL LLC
New Castle, DE, 19720
/PHARMADELUSA
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