SANATOS CHILDREN COUGH AND CONGESTION CHERRY- dextromethorphan hbr and guaifenesin liquid 
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 Children Cough & Congestion Cherry (APTA)

Drug Facts

Active Ingredients & Purposes

Active Ingredients
(in each 5 mL teaspoonful) 		Purposes
Dextromethorphan HBr 5 mgCough Suppressant
Guaifenesin 100 mgExpectorant

Uses

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a common cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain the bronchial tubes

Warnings

Do not use in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Do not use

  • in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use, if the child has a

  • cough that is accompanied by excessive phlegm (mucus)
  • persistent or chronic cough such as occurs with asthma

Stop use and ask a doctor, if the child has a

  • cough lasts more than 7 days, tends to come back, or accompained by fever, rash, or persistent headache. These could be signs of a serious condition.

KEEP OUT OF REACH OF CHILDREN.

In case of overdose, get medical help or contact Poison Control Center right away.

Directions

  • do not give a child more than 6 doses in any 24-hour period
AgeDose
Children 6 to under 12 years of age1-2 teaspoonfuls (tsps) every 4 hours
Children 2 to under 6 years of age½-1 teaspoonful (tsp) every 4 hours
Children under 2 years of ageconsult a doctor

Other information

  • sodium: 3 mg per teasponful
  • store at 20- 25º C (68- 77º F)
  • do not refrigerate
  • dosage cup included

TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING.

Inactive ingredients

Anhydrous citric acid, D&C red #33, dextrose monohydrate, FD&C red #40, flavors, glycerin, maltitol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sucralose, xanthan gum.

Questions?

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

Distributed by:

PHARMDEL LLC
Georgetown, DE 19702

Principal Display Panel

SanaTos®

Children


Cough & Chest Congestion

Cherry Flavor

COUGH SUPPRESANT• EXPECTORANT

Dextromethorphan HBr • Guafenesin

Helps Loosen Chest Congestion

  • ALCOHOL FREE
  • NON-DROWSY


For Ages 2 to 12

4 FL OZ (118 mL)

Sanatos Children

SANATOS CHILDREN COUGH AND CONGESTION CHERRY 
dextromethorphan hbr and guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-013
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
MALTITOL (UNII: D65DG142WK)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorredScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55758-013-041 in 1 BOX01/01/2016
1118 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/01/2016
Labeler - Pharmadel LLC (030129680)

Revised: 9/2023
Document Id: 05421acd-5d5f-bdb4-e063-6394a90a80d1
Set id: 60437d86-9e13-8d8a-e053-2991aa0a2317
Version: 3
Effective Time: 20230913
 
Pharmadel LLC