SANATOS SEVERE COLD AND COUGH NIGHTTIME- acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride granule, for solution

SanaTos Severe Cold and Cough Nighttime by

Drug Labeling and Warnings

SanaTos Severe Cold and Cough Nighttime by is a Otc medication manufactured, distributed, or labeled by Pharmadel LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Active Ingredients (in each packet)	Purposes
Acetaminophen 650 mg	Pain reliever/ fever reducer
Diphenhydramine HCI 25 mg	Antihistamine/ cough suppressant
Phenylephrine HCI 10 mg	Nasal decongestant

Uses

Temporarily relieves common cold/flu symptoms:

• minor aches & pains
• headache
• cough due to minor throat & bronchial irritation
• runny nose
• sneezing
• itching of the nose or throat
• itchy, watery eyes and nasal congestion due to hay fever or other upper respiratory allergies
• stuffy nose
• sinus congestion and pressure
• and reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

• more than 6 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

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

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.
• for more than 7 days for pain and 3 days for fever, unless directed by a doctor
• with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

• liver disease
• heart disease
• glaucoma
• high blood pressure
• thyroid disease
• diabetes
• a breathing problem, persistent chronic bronchitis or cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus), unless directed by a doctor
• trouble urinating due to enlarged prostate gland high blood pressure

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers

When using this product

• it may cause marked drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect
• avoid alcoholic beverages while taking this product
• use caution when driving a motor vehicle or operating machinery
• may cause excitability especially in children

Stop use and ask doctor if

• symptoms do not improve within 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
• new symptoms occur
• redness or swelling is present
• if 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
• take every 4 hours; do not take more than 6 packets in 24- hour period
• dissolve contents of one packet into 8 oz. hot water and sip while hot; consume entire drink within 10-15 minutes
• if using a microwave; add contents of one packet to 8 oz. of cool water, stir briskly before and after heating. Do not overheat.

• Age: Dose
• adults & children 12 yrs. of age & over: one packet every 4 hours
• children 6 to under 12 yrs. of age: do not use; unless directed by a doctor
• children under 6 yrs. of age: do not use

Other information

• each packet contains: potassium 10 mg, sodium 23 mg
• phenylketonurics: contains phenylalanine 13 mg per packet
• store at room temperature 68-77°F (20-25°C)
• protect from excessive heat and moisture

TAMPER EVIDENT: Do not use if packets are broken or torn.

Inactive ingredients

acesulfame potassium, aspartame, anhydrous citric acid, D&C yellow 10, FD&C blue 1, flavors, maltodextrin, silicon dioxide, sodium citrate, sucrose, tribasic calcium phosphate

Questions or Comments?

1-899-359-3478 (M-F) 9 AM to 5 PM Eastern or www.pharmadelusa.com

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Distributed by:

PHARMADEL

Georgetown, DE 19947

Made in India

PRINCIPAL DISPLAY PANEL

SanaTos ®

Severe COLD & COUGH

Acetaminophen Diphenhydramine HCI Phenylephrine HCI

Nighttime

RELIEF

• Nasal Congestion
• Cough
• Sore Throat
• Runny Nose
• Sneezing
• Headache
• Fever
• Body Ache

Lemon & Honey Flavored

INGREDIENTS AND APPEARANCE

SANATOS SEVERE COLD AND COUGH NIGHTTIME 
acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride granule, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55758-009
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg

Inactive Ingredients
Ingredient Name	Strength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
ASPARTAME (UNII: Z0H242BBR1)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SUCROSE (UNII: C151H8M554)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)

Product Characteristics
Color		Score
Shape		Size
Flavor	HONEY, LEMON	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55758-009-06	6 in 1 CARTON; Type 0: Not a Combination Product	02/20/2014
2	NDC: 55758-009-01	1 in 1 POUCH; Type 0: Not a Combination Product	02/20/2014
3	NDC: 55758-009-18	18 in 1 CARTON; Type 0: Not a Combination Product	03/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	02/20/2014

Labeler - Pharmadel LLC (030129680)