SANATOS MUCUS RELIEF COLD TODDLERS- dextromethorphan hbr, guaifenesin liquid 
Pharmadel LLC

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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

AgeDose
children 2 to under 6 years of age 2.5 mL every 4 hours
children under 2 years of age ask a doctor



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 DrugM01210/17/2017
Labeler - Pharmadel LLC (030129680)

Revised: 9/2023
Document Id: 05424b3d-72d2-cd9a-e063-6294a90a8d52
Set id: 60672feb-1421-651e-e053-2a91aa0af41d
Version: 3
Effective Time: 20230913
 
Pharmadel LLC