SANATOS CHILDREN COUGH AND CONGESTION CHERRY- dextromethorphan hbr and guaifenesin liquid 
Pharmadel LLC

----------

SanaTos Children Cough & Congestion Cherry (APTA)

Drug Facts

Active Ingredients & Purposes

Active Ingredients
(in each teaspoonful, 5 mL)
Purposes
Dextromethorphan HBr 5 mg .....Cough Suppressant
Guaifenesin 100 mg .....Expectorant

Uses

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.

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 that lasts more than 7 days, tends to recur, or is accompanied by fever, rash or a 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 a Poison Control Center right away

Directions

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

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
New Castle, DE 19720

Principal Display Panel

Saantos Children CC

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 DrugM01201/01/2016
Labeler - Pharmadel LLC (030129680)

Revised: 5/2024
Document Id: 177ee8db-2b19-2923-e063-6294a90a1c7b
Set id: 60437d86-9e13-8d8a-e053-2991aa0a2317
Version: 4
Effective Time: 20240502
 
Pharmadel LLC