Giltuss Honey Dm

Giltuss Honey Dm
SPL v1
SPL
SPL Set ID 3effaf4b-28c3-6131-e063-6294a90a17ff
Route
ORAL
Published
Effective Date 2020-06-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (15 mg)
Inactive Ingredients
Potassium Sorbate Honey Methylparaben Propylparaben Water Propylene Glycol Sucralose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-06-22

Description

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

Dosage and Administration

Dosage and administration Do not take more than 4 doses in any 24 hours period Keep sosage cup for use with this product children under 4 years, consult a doctor children 6 to under 12 years, 5ml every 6-8 hours children 12 years and over, 10ml every 6-8 hours


Medication Information

Warnings and Precautions

Do not use if your child is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs fotdepression, psychriatic or emotional condition, orParkinso's desese), or for 2 weeksafter stoppings the MAOI drugs. If you do not know if your child prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Indications and Usage

Do not take more than 4 doses in any 24 hours period Keep sosage cup for use with this product

children under 4 years, consult a doctor

children 6 to under 12 years, 5ml every 6-8 hours

children 12 years and over, 10ml every 6-8 hours

Dosage and Administration

Dosage and administration

Do not take more than 4 doses in any 24 hours period Keep sosage cup for use with this product

children under 4 years, consult a doctor

children 6 to under 12 years, 5ml every 6-8 hours

children 12 years and over, 10ml every 6-8 hours

Description

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

Section 50565-1

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

Section 50566-9

Stop use and ask a doctorif the child has a cough that last more than 7 days, comes back or is accompanied byfever, rash or persistent headache. These could be signs of a serius condition.

Section 50569-3

Ask a doctor before use if the child has couhg that occurs with too muchmucus

a persistent or chronic cough such as occurs with sthma.

Section 53413-1

Call 1-787-848-9114 Monday-Friday, 9AM-5PM EST

Call your doctor for medeical advice in the event of side effects.

Section 55105-1

Purpose section Cough Suppresant

Section 55106-9

Active ingredient (in each 5ml)

Active Ingredients ( in each 5 mL)

Dextromethorphan15mg

purpose cough suppresant

Section 60561-8

Temporarily relieves: cough due to minor thoroat and brochial irritation associated with the common cold or inhaled irritants

the intensity of coughing

The impulse to cough to help your child get to sleep

Inactive Ingredient

Inactive ingredients:

Natural and artificial flavor, natural grade A Honey, Methylparaben, potassium Sorbate, propylene Glycol, propylparaben, purified water, sucralose

Principal Display Panel

Children giltuss honey DM 4-12

Alcohol Free

DYE free

Non Drowsy

Certified Honey

Honey Lemon Flavor


Structured Label Content

Indications and Usage (34067-9)

Do not take more than 4 doses in any 24 hours period Keep sosage cup for use with this product

children under 4 years, consult a doctor

children 6 to under 12 years, 5ml every 6-8 hours

children 12 years and over, 10ml every 6-8 hours

Warnings and Precautions (34071-1)

Do not use if your child is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs fotdepression, psychriatic or emotional condition, orParkinso's desese), or for 2 weeksafter stoppings the MAOI drugs. If you do not know if your child prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctorif the child has a cough that last more than 7 days, comes back or is accompanied byfever, rash or persistent headache. These could be signs of a serius condition.

Section 50569-3 (50569-3)

Ask a doctor before use if the child has couhg that occurs with too muchmucus

a persistent or chronic cough such as occurs with sthma.

Section 53413-1 (53413-1)

Call 1-787-848-9114 Monday-Friday, 9AM-5PM EST

Call your doctor for medeical advice in the event of side effects.

Section 55105-1 (55105-1)

Purpose section Cough Suppresant

Section 55106-9 (55106-9)

Active ingredient (in each 5ml)

Active Ingredients ( in each 5 mL)

Dextromethorphan15mg

purpose cough suppresant

Section 60561-8 (60561-8)

Temporarily relieves: cough due to minor thoroat and brochial irritation associated with the common cold or inhaled irritants

the intensity of coughing

The impulse to cough to help your child get to sleep

Inactive Ingredient (Inactive ingredient)

Inactive ingredients:

Natural and artificial flavor, natural grade A Honey, Methylparaben, potassium Sorbate, propylene Glycol, propylparaben, purified water, sucralose

Principal Display Panel (Principal display panel)

Children giltuss honey DM 4-12

Alcohol Free

DYE free

Non Drowsy

Certified Honey

Honey Lemon Flavor

Dosage and Administration (Dosage and administration)

Dosage and administration

Do not take more than 4 doses in any 24 hours period Keep sosage cup for use with this product

children under 4 years, consult a doctor

children 6 to under 12 years, 5ml every 6-8 hours

children 12 years and over, 10ml every 6-8 hours


Advanced Ingredient Data


Raw Label Data

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