SANATOS CHILDRENS MUCUS RELIEF COUGH- dextromethorphan hydrobromide and guaifenesin liquid 
Pharmadel LLC

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SanaTos Children's Mucus Relief Cough (DEACTIVATED)

Drug Facts

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

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 id the child has

  • cough that occurs with too much phlegm (mucus)
  • 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

  • cough lasts more than 7 days, comes back or occurs with 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

AgeDose
Children 6 years to under 12 years1-2 teaspoonful s (tsps) every 4 hours
Children 4 years to under 6 years½-1 teaspoonful (tsp) every 4 hours
Children under 4 yearsdo not use

Other information

Inactive ingredients

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

Questions?

Call weekdays from 9:30 AM to 4:30 PM EST 1-877-798-5944

Distributed by
PHARMDEL®
Seaford, DE 19973

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

NDC # 55758-007-04

SanaTos®

Children's

Mucus Relief
COUGH
Cherry Flavor

Dextromethorphan HBr
Cough Suppressant

Guafenesin
Expectorant

Relieves Chest Congestion
Thins & Loosens Mucus

Alcohol-Free
For Ages 4 to 12

4 FL OZ (118 mL)

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton
SANATOS CHILDRENS MUCUS RELIEF COUGH 
dextromethorphan hydrobromide and guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-007
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
DEXTROSE (UNII: IY9XDZ35W2)  
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:55758-007-041 in 1 CARTON10/10/201301/01/2026
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01210/10/201301/01/2026
Labeler - Pharmadel LLC (030129680)

Revised: 5/2024
Document Id: 177ba1f5-b6cb-d546-e063-6294a90ab95b
Set id: 9a795760-3176-41bc-9a70-2f26efeef464
Version: 8
Effective Time: 20240502
 
Pharmadel LLC