SANATOS MUCUS RELIEF COLD TODDLERS- dextromethorphan hbr, guaifenesin liquid

SanaTos Mucus Relief Cold Toddlers by

Drug Labeling and Warnings

SanaTos Mucus Relief Cold Toddlers by is a Otc medication manufactured, distributed, or labeled by Pharmadel LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• temporarily relieves cough due to minor throat and bronchial irritation as may occur with a 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.

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

• do not give a child more than 6 doses in any 24-hour period
• repeat the dose every 4 hours
• measure with the dosing device provided
• do not use any other dosing device
• • Age: Dose
  • 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

• each dose (2.5 mL) contains: sodium 1.5 mg
• store between 20-25°C (68-77°F)
• oral dosing device included
• do not refrigerate
• Keep carton for full direction for use

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)

• ALCOHOL FREE
• NON-DROWSY

Includes Syringe

INGREDIENTS AND APPEARANCE

SANATOS MUCUS RELIEF COLD TODDLERS 
dextromethorphan hbr, guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55758-307
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	50 mg  in 2.5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	2.5 mg  in 2.5 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	red	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55758-307-02	59 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	10/17/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/17/2017

Labeler - Pharmadel LLC (030129680)