SANATOS SEVERE COLD AND COUGH DAY TIME- acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride granule, for solution 
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 Severe Cold and Cough Daytime

Drug Facts

Active ingredients (in each packet)Purposes
Acetaminophen 650 mgPain reliever/ fever reducer
Dextromethorphan HBr 20 mgCough suppressant
Phenylephrine HCI 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:

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

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 (MAOIs) (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 7 days for pain and 3 days for fever, unless directed by a doctor

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if

  • taking the blood thinning drug warafin

Stop use and ask a doctor if

  • a persistent cough or symptoms do not improve within 5 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
  • new symptoms occur
  • redness or swelling is present
  • nervousness, dizziness, or sleeplessness occur

If pregnant or breast-feeding, ask a health care 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

AgeDose
adults & children 12 yrs. of age & overone packet every 4 hours
children under 12 yrs. of agedo not use

Other information

TAMPER EVIDENT: Do not use if packets are broken or torn.

Inactive ingredients

acesulfame potassium, anhydrous citric acid, aspartame, FD&C blue 1, FD&C red 40, flavors, isopropyl alcohol, maltodextrin, silicon dioxide, sodium citrate, sucrose, tribasic calcium phosphate, water

Questions or Comments?

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

Distributed by/ Distribuido por:
PHARMADEL

Georgetown, DE 19947

Made in India

PRINCIPAL DISPLAY PANEL

SanaTos ® Severe COLD & COUGH

NDC 55758-010-01

NDC 55758-010-06

Box

SANATOS SEVERE COLD AND COUGH DAY TIME 
acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride granule, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-010
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
ASPARTAME (UNII: Z0H242BBR1)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
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)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55758-010-066 in 1 CARTON; Type 0: Not a Combination Product02/20/2014
2NDC:55758-010-011 in 1 POUCH; Type 0: Not a Combination Product02/20/2014
3NDC:55758-010-1818 in 1 CARTON; Type 0: Not a Combination Product03/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/20/2014
Labeler - Pharmadel LLC (030129680)

Revised: 6/2020
Document Id: a70979fb-c597-0e70-e053-2995a90ab78d
Set id: b995a0b2-898d-4a8f-b44f-097ae54e0ba5
Version: 5
Effective Time: 20200601
 
Pharmadel LLC