FDA Label for Sanatos Nighttime

Otc - Purpose

Uses

Temporarily relieves common cold/flu symptoms

• cough due to minor throat and bronchial irritation
• sore throat
• headache
• minor aches and pains
• runny nose
• sneezing
• itching of the nose or throat
• itchy, watery eyes due to hay fever
• and fever reducer

Warnings

Liver warning: 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 for this product
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks daily while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

• skin reddening
• blisters
• rash

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
• 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 an 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

• excitability may occur, especially in children
• may cause marked drowsiness; alcohol, sedatives, and tranquilizers may increase drowsiness effect
• avoid alcoholic drinks
• 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
• redness or swelling is present
• new symptoms occur
• cough comes back, occurs with a rash or a persistent 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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Other Information

• store between 68-77°F (20-25°C)
• avoid excessive heat
• do not use if blister pack is punctured or torn

Directions

• do not exceed recommended dosage (see Liver warning)
• do not exceed 4 doses in a 24 hour period or as directed by a doctor

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

Inactive Ingredients

D&C yellow #10, FD&C blue #1, gelatin, glycerin, methylparaben, polyethylene glycol, 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:

PHARMADEL LLC

New Castle, DE, 19720

/PHARMADELUSA