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SanaTos Severe Cold and Cough Day Time

Medically reviewed by Drugs.com. Last updated on Jun 1, 2020.

Dosage form: granule, for solution
Ingredients: ACETAMINOPHEN 650mg, DEXTROMETHORPHAN HYDROBROMIDE 20mg, PHENYLEPHRINE HYDROCHLORIDE 10mg
Labeler: Pharmadel LLC
NDC Code: 55758-010

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:

  • cough due to minor throat & bronchial irritation
  • headache
  • sore throat
  • minor aches & pains
  • nasal congestion due to hay fever
  • other upper respiratory allergies
  • sinus congestion and pressure
  • stuffy nose
  • reduces fever

Warnings

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

  • more than 6 packets 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 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 (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
  • do not exceed recommended dosage
  • take every 4 hours; do not exceed 6 packets in a 24-hour period
  • dissolve contents of one packet into 8 oz. of hot water and sip while hot; consume entire drink within 10-15 minutes
  • if using a microwave; add contents of one packet to 8 oz. of cool water, stir briskly before and after heating. Do not overheat.

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

Other information
  • each packet contains: potassium 10 mg, sodium 27 mg
  • phenylketonurics: contains phenylalanine 14 mg per packet
  • store at room temperature 68-77°F (20-25°C)
  • protect from excessive heat and moisture

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

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 AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN650 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE20 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL ALCOHOL 
ACESULFAME POTASSIUM 
ASPARTAME 
ANHYDROUS CITRIC ACID 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
MALTODEXTRIN 
SILICON DIOXIDE 
SODIUM CITRATE 
SUCROSE 
TRIBASIC CALCIUM PHOSPHATE 
WATER 
Product Characteristics
Color    Score    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:55758-010-066 GRANULE, FOR SOLUTION in 1 CARTON
2NDC:55758-010-011 GRANULE, FOR SOLUTION in 1 POUCH
3NDC:55758-010-1818 GRANULE, FOR SOLUTION in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/20/2014
Labeler - Pharmadel LLC (030129680)

 
Pharmadel LLC

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.