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 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 6 hours
• children 6 years to under 12 years: 15 mL (1 TTBSP) 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

Alcholo-Free / Antihistamine Free

NDC: 55758-022-06

Sanatos® Daytime

Multi-Symprom Cold & Flu Relief

Acetaminophen,

Dextromethrophan HBr, Phenylephrine HCI

• Minor Aches & Pains, Fever
• Sore Throat
• Nasal Decongestion
• Cough

New & Improved

Non-Drowsy

6 FL OZ (177mL)

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55758-022
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)
SUCRALOSE (UNII: 96K6UQ3ZD4)
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: 55758-022-06	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 final	part341	12/01/2014

Labeler - Pharmadel LLC (030129680)