SANATOS SEVERE COLD RELIEF NIGHTTIME- acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride granule, for solution 
Pharmadel LLC

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SanaTos Nighttime EHL Powder (AS)

Drug Facts

Drug Facts

Active ingredients & Purposes

Active Ingredients (in each packet)Purposes
Acetaminophen 650 mgPain reliever/ fever reducer
Diphenhydramine HCL 25 mgAntihistamine/ cough suppressant
Phenylephrine HCL 10 mgNasal decongestant

Uses

Temporarily relieves common cold/flu symptoms:

Warnings

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

Sore throat warning: 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

  • 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.
  • with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you

  • have liver disease
  • have heart disease
  • have high blood pressure
  • have thyroid disease
  • have diabetes
  • have glaucoma
  • have a breathing problem such as emphysema
  • have difficulty urinating due to an enlarged prostate gland
  • have a breathing problem such as emphysema or chronic bronchitis
  • are taking sedatives or tranquilizers

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin

When using this product

  • do not exceed recommended dosage

  • may cause excitability, especially in children
  • use caution when driving a motor vehicle or operating machinery
  • may cause marked drowsiness

Stop use and ask doctor if

  • nervousness, dizziness, or sleeplessness occur
  • redness or swelling is present
  • pain, cough, or nasal congestion persists or gets worse or last more than 7 days
  • fever gets worse or lasts more than 3 days
  • any new symptoms occur
  • cough comes back or occurs with rash or 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.

Directions

Other information

Inactive ingredients

acesulfame potassium, anhydrous citric acid, aspartame, D&C yellow #10, eucalyptus honey lemon flavors, FD&C blue #1, FD&C red #40, isopropyl alcohol, maltodextrin, silicon dioxide, sodium citrate, sucrose, tribasic calcium phosphate, water

Questions?

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

Distributed by:

PHARMADEL LC

New Castle, DE 19720

Made in India

PRINCIPAL DISPLAY PANEL

SN EHL PDP

SANATOS  SEVERE COLD RELIEF NIGHTTIME
acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride granule, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-385
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
WATER (UNII: 059QF0KO0R)  
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
ASPARTAME (UNII: Z0H242BBR1)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SUCROSE (UNII: C151H8M554)  
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
Product Characteristics
Color    Score    
ShapeSize
FlavorHONEY, LEMON (Eucalyptus Honey Lemon) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55758-385-066 in 1 CARTON; Type 0: Not a Combination Product03/31/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01203/31/2024
Labeler - Pharmadel LLC (030129680)

Revised: 3/2024
Document Id: 14ac5b88-5dcc-7bc2-e063-6294a90a7646
Set id: 144aafcc-6ec2-a322-e063-6294a90afc27
Version: 7
Effective Time: 20240327
 
Pharmadel LLC