SANATOS CHILDRENS MUCUS RELIEF COUGH- dextromethorphan hydrobromide and guaifenesin liquid

SanaTos Childrens Mucus Relief Cough by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENT

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

Uses

• 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 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

• do not take more than 6 doses in any 24-hour period

Age	Dose
Children 6 years to under 12 years	1-2 teaspoonful s (tsps) every 4 hours
Children 4 years to under 6 years	½-1 teaspoonful (tsp) every 4 hours
Children under 4 years	do not use

Other information

• each teaspoon contains: sodium 3 mg
• store between 20-25 C (68-77 F)
• do not refrigerate
• dosage cup provided
• Keep cartoon for full directions for use

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

SPL UNCLASSIFIED SECTION

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)

INGREDIENTS AND APPEARANCE

SANATOS CHILDRENS MUCUS RELIEF COUGH 
dextromethorphan hydrobromide and guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55758-007
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	5 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55758-007-04	1 in 1 CARTON	10/10/2013
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/10/2013

Labeler - Pharmadel LLC (030129680)