Sanatos Children Cough & Congestion Cherry (apta)

Drug Facts

Composition & Product

Active Ingredients

Guaifenesin (100 mg) Dextromethorphan (5 mg)

Inactive Ingredients

Anhydrous Citric Acid Dextrose Monohydrate D&c Red No. 33 Fd&c Red No. 40 Glycerin Maltitol Propylene Glycol Water Saccharin Sodium Sodium Benzoate Sucralose Xanthan Gum

Identifiers & Packaging

Pill Appearance

Color: red

Marketing Status

OTC MONOGRAPH DRUG Active Since 2016-01-01

Medication Information

Description

Active Ingredients (in each teaspoonful, 5 mL) 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

Section 55105-1

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

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 teaspoonfuls (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

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.

Questions?

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

Distributed By:

PHARMDEL LLC

New Castle, DE 19720

Other Information

per teaspoonful (5mL) contains: 3mg Sodium
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.

Principal Display Panel

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away

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 that lasts more than 7 days, tends to recur, or is accompanied by fever, rash or a persistent headache. These could be signs of a serious condition.

Structured Label Content

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

Section 55105-1 (55105-1)

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

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 teaspoonfuls (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

Do Not Use (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.

Questions?

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

Distributed By: (Distributed by:)

PHARMDEL LLC

New Castle, DE 19720

Other Information (Other information)

per teaspoonful (5mL) contains: 3mg Sodium
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 (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.

Principal Display Panel

Keep Out of Reach of Children. (KEEP OUT OF REACH OF CHILDREN.)

In case of overdose, get medical help or contact a Poison Control Center right away

Ask A Doctor Before Use, If the Child Has A (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 (Stop use and ask a doctor, if the child has a)

cough that lasts more than 7 days, tends to recur, or is accompanied by fever, rash or a persistent headache. These could be signs of a serious condition.

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

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