SANATOS NIGHTTIME MULTI SYMPTOMS- acetaminophen, dextromethorphan hbr, doxylamine succinate liquid 
Pharmadel LLC

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Sanatos MS Nighttime 6 (Deactivated)

Drug Facts

Active Ingredients & Purposes

Active ingredients (in each 30 mL dose cup) Purposes
Acetaminophen 650 mgPain reliever/fever reducer
Dextromethorphan HBr 30 mgCough suppressant
Doxylamine succinate 12 mgAntihistamine

Uses

temporarily relieves these common cold/flu symptoms:

  • sore throat
  • headache
  • minor aches and pains
  • fever
  • runny nose and sneezing
  • cough due to minor throat and bronchial irritation

Warnings

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

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks everyday 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.

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.
  • to make a child sleepy

Ask a doctor before use if you have

  • a sodium-restricted diet
  • liver disease
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or 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

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

When using this product

  • do not use more than directed
  • avoid alcoholic drinks
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, and tranquilizers may increase drowsiness

Stop use and ask a doctor if

  • redness or swelling is present
  • symptoms do not get better within 7 days or are accompanied by fever
  • fever gets worse or lasts more than 3 days
  • cough lasts more than 7 days, comes back, or occurs with fever, 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.

Overdose warning:

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

  • take only as recommended - see Overdose warning
  • use dose cup or tablespoon (TBSP)
  • do not exceed 4 doses per 24 hours
agedose
adults & children 12 years & over 30 mL(2TBSP) every 6 hours
children 4 to under 12 yearsask a doctor
children under 4 years do not use
  • If taking Nighttime at night and Daytime during the day, limit total to 4 doses per 24 hours.

Other informaiton

  • each 30 mL dose cup contains: sodium 45 mg
  • store at room temperature

Tamper Evident: Do not use if imprinted shrink band is missing or broken.

Inactive ingredients

citric acid, D&C yellow#10, FD&C Green# 3, FD&C yellow# 6, flavor, glycerin, polythylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sucrose

Questions?

call 1-866-359-3478

Distributed by:

Pharmadel LLC

Seaford, DE 19973

www.sanatos.com

Princpal Display Panel

Alcohol- Free / Original Flavor

SanaTos®

Nighttime

MULTI-SYMPTOMS COLD

& FLU RELIEF

Acetaminophen,

Dextromethorphan HBr, Doxylamine Succinate

  • Minor Aches & Pains, Fever
  • Sore Throat
  • Sneezing, Runny Nose
  • Cough

NEW & IMPROVED

6 FL OZ (177 mL)

Sanatos Nighttime MS

SANATOS NIGHTTIME MULTI SYMPTOMS 
acetaminophen, dextromethorphan hbr, doxylamine succinate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-023
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 30 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE12.5 mg  in 30 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SUCROSE (UNII: C151H8M554)  
WATER (UNII: 059QF0KO0R)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
GLYCERIN (UNII: PDC6A3C0OX)  
Product Characteristics
ColorgreenScore    
ShapeSize
FlavorANISE (Medicinal) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55758-023-06177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/01/201412/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01312/01/201412/01/2017
Labeler - Pharmadel LLC (030129680)

Revised: 11/2023
 
Pharmadel LLC