SANATOS MUCUS RELIEF COLD TODDLERS- dextromethorphan hbr, 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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Santos Toddler Mucus Relief Cough (Apta)

Drug Facts

Active Ingredients & Purposes

Active ingredients (in each 2.5 mL)Purposes
Dextromethorphan HBr 2.5 mg .....

Cough suppressant

Guaifenesin 50 mg............Expectorant

Use

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

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

When using this product

do not use more than directed

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

cough persists for more than 1 week, tends to recur, or is accompanied 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 a Poison Control Center right away.

Directions

Other information

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 or comments?

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

Principal Display Panel

Sanatos

Toddlers

Mucus Relief

Cough

Dextromethorphan HBr........Cough Suppressant

Guaifenesin...............................................Expectorant

FOR CHILDREN 2 TO UNDER 6 YEARS

Cherry Flavor

2 FL OZ (59 mL)


Includes Syringe

Sanatos Toddlers

SANATOS MUCUS RELIEF COLD TODDLERS 
dextromethorphan hbr, guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-307
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN50 mg  in 2.5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE2.5 mg  in 2.5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
MALTITOL (UNII: D65DG142WK)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorredScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55758-307-0259 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product10/17/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/17/2017
Labeler - Pharmadel LLC (030129680)

Revised: 1/2022
Document Id: d57ac4cd-47af-488b-e053-2995a90a7c62
Set id: 60672feb-1421-651e-e053-2a91aa0af41d
Version: 2
Effective Time: 20220113
 
Pharmadel LLC