SANATOS MULTI SYMPTOM- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hci tablet 
Pharmadel LLC

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.

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SanaTos MS Display 2x50 - Vovantis

Drug Facts

Active Ingredient & Purposes

Active ingredients (in each tablet)Purposes
Acetaminophen 325 mgPain reliever/ fever reducer
Dextromethorphan HBr 15 mgCough suppressant
Guaifenesin 200 mg

Expectorant

Phenylephrine HCI 5 mgNasal decongestant

Uses

Temporarily relieves common cold/flu symptoms:

Warnings

Liver Warning:

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

  • more than 8 tablets 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 may cause severe skine 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 vomitting, consult a doctor promptly.

Do not use

  • with any 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, asl a doctor or pharmacist before taking this product.
  • for more than 7 days for pain and 3 days or fever, unless directed by a doctor.

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • high blood pressure
  • throid disease
  • diabetes
  • trouble urinating due to enlarged prostate gland
  • a cough that is accompained by excessive phlegm (mucus)
  • a persistant or chronic cough such as occurs with smoking, asthma or emphysema

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin

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

TAMPER EVIDENCE: Do not use if packet is open or torn.

Inactive ingredients

corn starch, microcrystalline cellulose, povidone-iodine, povidone k30, silicone dioxide, stearic acid, talc

Questions & comments?


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

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SANATOS MULTI SYMPTOM 
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hci tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-361
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
POVIDONE K30 (UNII: U725QWY32X)  
TALC (UNII: 7SEV7J4R1U)  
STARCH, CORN (UNII: O8232NY3SJ)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POVIDONE-IODINE (UNII: 85H0HZU99M)  
Product Characteristics
ColorwhiteScorescore with uneven pieces
ShapeOVALSize17mm
FlavorImprint Code A12
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55758-361-022 in 1 PACKET; Type 0: Not a Combination Product08/01/2020
2NDC:55758-361-9950 in 1 CARTON08/01/2020
2NDC:55758-361-022 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/01/2020
Labeler - Pharmadel LLC (030129680)

Revised: 5/2022
Document Id: df260190-89e6-b338-e053-2995a90a32cb
Set id: df260190-89e7-b338-e053-2995a90a32cb
Version: 1
Effective Time: 20220520
 
Pharmadel LLC