Label: SANATOS DAY AND NIGHT MULTI SYMPTOM- acetaminophen,dextromethorphan hbr,doxylamine succinate kit
- NDC Code(s): 55758-142-24
- Packager: Pharmadel
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated December 7, 2019
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- Official Label (Printer Friendly)
- Drug Facts
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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
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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
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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.
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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
- Inactive ingredients
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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 sueñoDaytime Liquicaps
12 Liquicaps de DiaSanatos ®
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
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INGREDIENTS AND APPEARANCE
SANATOS DAY AND NIGHT MULTI SYMPTOM
acetaminophen,dextromethorphan hbr,doxylamine succinate kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55758-142 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55758-142-24 1 in 1 CARTON 09/30/2018 1 1 in 1 BLISTER PACK; Type 1: Convenience Kit of Co-Package Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BLISTER PACK 12 Part 2 1 BLISTER PACK 12 Part 1 of 2 SANATOS DAYTIME MULTI SYMPTOM
acetaminophen,dextromethorphan hbr, phenylephrine hcl capsule, liquid filledProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg Inactive Ingredients Ingredient Name Strength 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 Color orange (Liquicap) Score score with uneven pieces Shape OVAL Size 21mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 1 in 1 CARTON 1 12 in 1 BLISTER PACK; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 09/30/2018 Part 2 of 2 SANATOS NIGHTTIME MULTI SYMPTOM
acetaminophen,dextromethorphan hbr, doxylamine succinate capsule, liquid filledProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 15 mg Inactive Ingredients Ingredient Name Strength 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 Color green (Liquicap) Score score with uneven pieces Shape OVAL Size 21mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 1 in 1 CARTON 1 12 in 1 BLISTER PACK; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 09/30/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part341 09/30/2018 Labeler - Pharmadel (030129680)