SANATOS DAY AND NIGHT MULTI SYMPTOM- acetaminophen,dextromethorphan hbr,doxylamine succinate 
Pharmadel

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 Daytime & Nightime Liquicaps 12/12

Drug Facts

Active ingredients and Purposes

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:

Nighttime Relief

Temporarily relieves common cold/flu symptoms:

Warnings

Liver Warning:

Daytime & Nighttime

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

Allergy Alert: Acetaminophen

Daytime & Nighttime

may cause severe skin reactions.
Symptoms may include:

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

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

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

Nighttime Liquicaps
12 Liquicaps de Noche

Sanatos 12-12

SANATOS DAY AND NIGHT MULTI SYMPTOM 
acetaminophen,dextromethorphan hbr,doxylamine succinate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-142
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55758-142-241 in 1 CARTON09/30/2018
11 in 1 BLISTER PACK; Type 1: Convenience Kit of Co-Package
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BLISTER PACK 12 
Part 21 BLISTER PACK 12 
Part 1 of 2
SANATOS DAYTIME MULTI SYMPTOM 
acetaminophen,dextromethorphan hbr, phenylephrine hcl capsule, liquid filled
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
Inactive Ingredients
Ingredient NameStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
GELATIN (UNII: 2G86QN327L)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SORBITAN (UNII: 6O92ICV9RU)  
Product Characteristics
Colororange (Liquicap) Scorescore with uneven pieces
ShapeOVALSize21mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11 in 1 CARTON
112 in 1 BLISTER PACK; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34309/30/2018
Part 2 of 2
SANATOS NIGHTTIME MULTI SYMPTOM 
acetaminophen,dextromethorphan hbr, doxylamine succinate capsule, liquid filled
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
Inactive Ingredients
Ingredient NameStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
GELATIN (UNII: 2G86QN327L)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SORBITAN (UNII: 6O92ICV9RU)  
Product Characteristics
Colorgreen (Liquicap) Scorescore with uneven pieces
ShapeOVALSize21mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11 in 1 CARTON
112 in 1 BLISTER PACK; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34309/30/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34109/30/2018
Labeler - Pharmadel (030129680)

Revised: 12/2019
Document Id: 9922b450-cf89-5ab5-e053-2995a90a8b5a
Set id: 7650c4bc-9dad-dde0-e053-2a91aa0aa20b
Version: 2
Effective Time: 20191207
 
Pharmadel