FDA.reportPublic FDA data

Sanatos

Manufacturer
Pharmadel LLC
Effective date
2025-08-27
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 20:34:47

Label at a glance#

ProductSanatos Nighttime
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Label structure9 sections

Indications and uses

Temporarily relieves common cold/flu symptoms cough due to minor throat and bronchial irritation headache minor aches and pains fever runny nose sneezing itching of the nose or throat itchy, watery eyes due to hay fever

Dosage and administration

do not exceed recommended dosage (see Liver warning) do not exceed 4 doses in a 24 hour period or as directed by a doctor Age Dose adults and children 12 years and older 2 softgels every 6 hours children 4 to under 12 years consult a doctor children under 4 years do not use

Label contents#

Full prescribing information#

Active Ingredients and Purposes

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each softgel)Purposes
Acetaminophen 325 mg ..............

Pain reliever/ fever reducer

Dextromethorphan HBr 15 mg ......Cough suppressant
Doxylamine succinate 6.25 mg .....Antihistamine

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves common cold/flu symptoms

  • cough due to minor throat and bronchial irritation
  • headache
  • minor aches and pains
  • fever
  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes due to hay fever

Warnings

WARNINGS SECTION

Liver warning: 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 for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily 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.

Do not use

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

When using this product

OTC - WHEN USING SECTION

  • may cause marked drowsiness
  • excitability may occur, especially in children
  • may cause marked drowsiness; alcohol, sedatives and tranquilizers may increase drowsiness effect
  • avoid alcoholic drinks when taking this product
  • use caution when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • pain or cough gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back or occurs with a rash or a persistent headache that lasts.

These could be signs of a serious condition.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • do not exceed recommended dosage (see Liver warning)
  • do not exceed 4 doses in a 24 hour period or as directed by a doctor
Age Dose
adults and children 12 years and older 2 softgels every 6 hours
children 4 to under 12 yearsconsult a doctor
children under 4 years do not use

Other information

OTHER SAFETY INFORMATION

  • store between 68-77°F (20-25°C)
  • avoid excessive heat
  • do not use if blister pack is punctured or torn

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C yellow #10, FD&C blue #1, gelatin, glycerin, methylparaben, polyethylene glycol, povidone k-30, propylene glycol, propylparaben, sorbitol, titanium dioxide, water.

Questions or comments?

OTC - QUESTIONS SECTION

+1-866-359-3478 (M-F) 9 AM - 5 PM EST or www.pharmadel.com

Distributed by:

SPL UNCLASSIFIED SECTION

PHARMADEL LLC

New Castle, DE, 19720

/PHARMADELUSA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

sanatos PDP nightsanatos PDP night

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55758-04255758-042-08

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C BLUE NO. 1H3R47K3TBDIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
POVIDONE K30U725QWY32XIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
DOXYLAMINE SUCCINATEV9BI9B5YI2ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
3d59b09c-5639-eebb-e063-6394a90aa7c622f53268-8979-c34e-e063-6394a90a668d2025-08-27WarningsExact identifier
spl id: 3d59b09c-5639-eebb-e063-6394a90aa7c6
spl set id: 22f53268-8979-c34e-e063-6394a90a668d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.