FDA Label for Sanatos Day And Night Multi Symptom
View Indications, Usage & Precautions
Sanatos Day And Night Multi Symptom Product Label
The following document was submitted to the FDA by the labeler of this product Pharmadel. 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
Daytime Relief
Active ingredients (in each liquicap) | Purposes |
Acetaminophen 325 mg....... | Pain reliever/ fever reducer |
Dextromethorphan HBr 10 mg.............. | Cough suppressant |
Phenylephrine HCI 5 mg....................... | Nasal decongestant |
Nighttime Relief
Active ingredients (in each liquicap) | Purposes |
Acetaminophen 325 mg........ | Pain reliever/ fever reducer |
Dextromethorphan HBr 15 mg............... | Cough suppressant |
Doxylamine succinate 6.25 mg........................ | Antihistamine |
Use
Daytime Relief
Temporarily relieves common cold/flu symptoms:
- headache
- minor aches and pains
- sore throat
- nasal and sinus congestion
- stuffy nose Temporarily reduces fever
- cough due to minor throat and bronchial irritation
- headache
- minor aches and pains
- sneezing
- sore throat
- runny nose
- itchy nose or throat
- itchy, watery eyes due to hay fever
- Temporarily reduces fever
Nighttime Relief
Temporarily relieves common cold/flu symptoms:
Warnings
Liver Warning:
Daytime & Nighttime
This product contains acetaminophen.
Severe liver damage may occur if you take
- more than 4 doses 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
- skin reddening
- blisters
- rash If a skin reaction occurs, stop use and seek medical help right away.
Allergy Alert: Acetaminophen
Daytime & Nighttime
may cause severe skin reactions.
Symptoms may include:
Sore throat warning:
Daytime & Nighttime
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
Daytime & Nighttime
- 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
- for more than 3 days for fever, unless directed by a doctor
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 You Have
Daytime
- 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 enlarged prostate gland
- liver disease
- glaucoma
- a cough that is accompanied by excessive phlegm (mucus)
- a breathing problem, persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis or emphysema
- trouble urinating due to enlarged prostate gland
Nighttime
Ask A Doctor Or Pharmacist Before Use If You Are
Daytime
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
- taking bloodthinning drug warfarin
Nighttime
Stop Use And Ask A Doctor If
Daytime
- symptoms do not improve within 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache.
- new symptoms occur
- redness or swelling is present
- nervousness, dizziness, or sleeplessness occur.These could be signs of a serious condition.
- pain or cough gets worse or lasts more than 5 days
- redness or swelling is present
- new symptoms occur
- cough comes back, occurs with rash or a persistent headache that lasts. These could be signs of a serious condition.
Nighttime
If Pregnant Or Breast-Feeding,
Daytime & Nighttime
ask a health professional before use.
Keep Out Of Reach Of Children.
Daytime & Nighttime
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
Daytime & Nighttime
- take only as directed
- do not exceed 4 doses in a 24-hour period
- even if taking both Daytime and Nighttime, total limit per day is 4 doses per 24 hour period
- adults & children 12 years & over: take two (2) liquicaps with water every 4 hours
- children 4 to under 12 years consult a doctor
- children under 4 years: do not use
Other Information
Daytime & Nighttime
store at room temperature 68-77°F (20-25°C)
Inactive Ingredients
Daytime
FD&C yellow #6, FD&C red #40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol,
Nighttime
D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol, sorbitan, titanium dioxide.
Principal Display Panel
Sanatos ®
MULTI SYMPTOM / MULTI SÍNTOMAS
Daytime Relief / Alivio Durante el Día
Acetaminophen, Dextromethorphan HBr,
Phenylephrine HCI/Acetaminofén, Dextrometorfano HBr, Fenilefrina HCI
- Sore Throat / Dolor de Garganta
- Nasal Congestion / Congestión Nasal
- Aches & Fever / Dolores y Fiebre
- Headache / Dolor de Cabeza
- Cough / Tos
- Sore Throat / Dolor de Garganta
- Aches & Fever / Dolor y Fiebre
- Runny Nose / Secreción Nasal
- Sneezing / Estornudos
- Cough / Tos
Non-Drowsy
No causa sueño
Daytime Liquicaps
12 Liquicaps de Dia
Sanatos ®
Nighttime Relief/Alivio Durante la Noche
Acetaminophen, Dextromethorphan HBr,
Doxylamine Succinate
Acetaminofén, Dextrometorfano HBr,
Sucinato de Doxilamina
Nighttime Liquicaps
12 Liquicaps de Noche
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