MedPath

Sanatos

Sanatos Nightime Softgel (HHH Pharma)

Approved
Approval ID

3dd3ed85-0c0a-8390-e063-6294a90a668e

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 2, 2025

Manufacturers
FDA

Pharmadel LLC

DUNS: 030129680

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code55758-510
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 2, 2025
FDA Product Classification

INGREDIENTS (13)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
SORBITANInactive
Code: 6O92ICV9RU
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
ACETAMINOPHENActive
Quantity: 325 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
DEXTROMETHORPHAN HYDROBROMIDEActive
Quantity: 15 mg in 1 1
Code: 9D2RTI9KYH
Classification: ACTIB
DOXYLAMINE SUCCINATEActive
Quantity: 6.25 mg in 1 1
Code: V9BI9B5YI2
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/1/2025

Principal Display Panel

PDP Sanatos Night

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/1/2025

Uses

Temporarily relieves cough-cold symptoms

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/1/2025

Inactive ingredients

D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol 400, povidone k-30, propylene glycol, sorbitol sorbitan solution, water

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/1/2025

Questions or comments?

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

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 9/1/2025

Other information

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

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 9/1/2025

Dist by/ por:

PHARMADEL LLC

New Castle, DE 19720

www.pharmadel.com

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/1/2025

Active Ingredients and Purposes

.

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

WARNINGS SECTION

LOINC: 34071-1Updated: 9/1/2025

Warnings

Liver warning:This product containsacetaminophen. Severe liver damage may occur if you take

  • more than** 8 softgels 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: Acetaminophenmay 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

  • 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.

Ask a doctor before use if you have

  • liver disease
  • glaucoma
  • a cough that is accompanied by excessive phlegm (mucus)
  • a persistent or chronic cough as occurs with smoking, asthma or emphysema
  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty urinating due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

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

When using this product

  • may cause marked drowsiness
  • excitability may occur, especially in children
  • 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

  • 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,

ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN.

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.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/1/2025

Directions

Age

Dose

adults and children 12 years and older

2 softgels every 6 hours,do not exceed 8 softgels in a 24 hour period

children 4 to under 12 years

consult a doctor

children under 4 years

do not use

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Sanatos - FDA Drug Approval Details