SANATOS MULTI SYMPTOM DAYTIME- acetaminophen, dextromethorphan hbr, phenylephrine hci liquid

Sanatos Multi Symptom Daytime by

Drug Labeling and Warnings

Sanatos Multi Symptom Daytime by is a Otc medication manufactured, distributed, or labeled by Pharmadel LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients & Purposes

• Active ingredients (in each 15 mL, 1 tablespoon): Purposes
• Acetaminophen 325 mg: Pain reliever/fever reducer
• Dextromethorphan HBr 10 mg: Cough suppressant
• Phenylephrine HCI 5 mg: Nasal decongestant

Uses

temporarily relieves common cold/flu symptoms:

• minor aches & pains
• headache
• sore throat
• fever
• nasal congestion
• cough due to minor throat and bronchial irritation

Warnings

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

• adults take more than 4,000 mg if acetaminophen in 24 hours
• child take more than 5 doses in 24 hours
• taken with other drugs containing acetaminophen
• adult has 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

• 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.
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if you have

• liver disease
• heart disease
• thyroid disease
• diabetes
• high blood pressure
• trouble urinating due to enlarged prostate gland
• persistent or chronic cough such as occurs with smoking, asthma, or emphysema
• cough that occurs with too much phlegm (mucus)

When using this product

• do not use more than directed (see overdose warning)
• avoid alcoholic drinks

Stop use and ask a doctor if

• you get nervos, dizzy or sleepless
• new symptoms occur
• fever gets worse or lasts more than 3 days
• pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
• redness or swelling is present
• 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 this and all drugs out of reach of children.

Overdose warning:

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.

Directions

• take only as recommended (see overdose warning)
• use a dosage cup or tablespoon (TBSP)
• do not exceed 4 doses per 24 hrs

• age: dose
• adults & children 12 years & over: 30 mL (2 TBSP) every 4 hours
• children 6 years to under 12 years: 15 mL (1 b TBSP) every 4 hours
• children 4 years to under 6 years: ask a doctor
• children under 4 years: do not use

• when using daytime and nighttime products, carefully read each label to ensure correct dosing.

Other information

• sodium content per tablespoon: 10 mg
• store at room temperature

TAMPER EVIDENT: Do not use if imprinted band is missing or broken.

Inactive ingredients

citric acid, FD&C yellow #6, flavor, glycerin, propylene glycol, purfied water, saccarhin sodium, sodium benzoate, sucrose

Questions?

call 1-866-359-3478

Distributed by:

Pharmadel LLC

Seaford, DE 19973

www.sanatos.com

Principal Display Panel

INGREDIENTS AND APPEARANCE

SANATOS MULTI SYMPTOM DAYTIME 
acetaminophen, dextromethorphan hbr, phenylephrine hci liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55758-055
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 15 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg  in 15 mL
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
WATER (UNII: 059QF0KO0R)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GLYCERIN (UNII: PDC6A3C0OX)
SUCROSE (UNII: C151H8M554)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Product Characteristics
Color	orange	Score
Shape		Size
Flavor	ORANGE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55758-055-06	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/01/2014	12/01/2014
2	NDC: 55758-055-25	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/01/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	12/01/2014

Labeler - Pharmadel LLC (030129680)