Sanatos Multi Symptoms Day and Night 24 Gelcaps Dual Pack

Sanatos by

Drug Labeling and Warnings

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

Drug Details [pdf]

SANATOS- acetaminophen, dextromethorphan hbr, phenylephrine hci, doxylamine succinate capsule, liquid filled 
Pharmadel LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Sanatos Multi Symptoms Day and Night 24 Gelcaps Dual Pack

Drug Facts

Active Ingredients

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

Nighttime Relief

Temporarily relieves common cold/flu symptoms:

  • 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

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

Allergy Alert: Acetaminophen

Daytime & Nighttime

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:

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

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

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

Nighttime

  • 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

Ask a doctor or pharmacist before use if you are

Daytime

  • taking the blood thinning drug warfarin

Nighttime

  • taking sedatives or tranquilizers
  • taking bloodthinning drug warfarin

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.

Nighttime

  • 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.

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

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

  • Sore Throat / Dolor de Garganta
  • Aches & Fever / Dolor y Fiebre
  • Runny Nose / Secreción Nasal
  • Sneezing / Estornudos
  • Cough / Tos

Nighttime Liquicaps
12 Liquicaps de Noche

Sanatos 2 in 1

SANATOS 
acetaminophen, dextromethorphan hbr, phenylephrine hci, doxylamine succinate capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 55758-141
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SORBITAN (UNII: 6O92ICV9RU)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
Colororange, green (and Orange) Scorescore with uneven pieces
ShapeOVALSize21mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 55758-141-241 in 1 PACKAGE, COMBINATION; Type 1: Convenience Kit of Co-Package09/26/201902/28/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/26/201902/28/2020
Labeler - Pharmadel LLC (030129680)

Revised: 3/2020
 
Pharmadel LLC