SANATOS CHILDREN COUGH AND CONGESTION CHERRY- dextromethorphan hbr and guaifenesin liquid

SanaTos Children Cough and Congestion Cherry by

Drug Labeling and Warnings

SanaTos Children Cough and Congestion Cherry 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 5 mL teaspoonful)	Purposes
Dextromethorphan HBr 5 mg	Cough Suppressant
Guaifenesin 100 mg	Expectorant

Uses

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

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 a

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

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

• cough lasts more than 7 days, tends to come back, or accompained 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 Poison Control Center right away.

Directions

do not give a child more than 6 doses in any 24-hour period

Age	Dose
Children 6 to under 12 years of age	1-2 teaspoonful s (tsps) every 4 hours
Children 2 to under 6 years of age	½-1 teaspoonful (tsp) every 4 hours
Children under 2 years of age	consult a doctor

Other information

• sodium: 3 mg per teasponful
• store at 20- 25º C (68- 77º F)
• do not refrigerate
• dosage cup included

TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING.

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?

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

Distributed by:

PHARMDEL®
Seaford, DE 19973

Principal Display Panel

SanaTos®

Children

Cough & Chest Congestion

Cherry Flavor

COUGH SUPPRESANT EXPECTORANT

Dextromethorphan HBr Guafenesin

Helps Loosen Chest Congestion

• ALCOHOL FREE
• NON-DROWSY

For Ages 2 to 12

4 FL OZ (118 mL)

INGREDIENTS AND APPEARANCE

SANATOS CHILDREN COUGH AND CONGESTION CHERRY 
dextromethorphan hbr and guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55758-013
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 MONOHYDRATE (UNII: LX22YL083G)
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: 55758-013-04	1 in 1 BOX	01/01/2016
1		118 mL in 1 BOTTLE, WITH APPLICATOR; 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	01/01/2016

Labeler - Pharmadel LLC (030129680)