Children's Giltuss Honey Cough & Chest Congestion

Children's Giltuss Honey Cough & Chest Congestion
SPL v1
SPL
SPL Set ID 3f909bc2-eb84-a19d-e063-6294a90ae04e
Route
ORAL
Published
Effective Date 2018-10-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (10 mg) Guaifenesin (100 mg)
Inactive Ingredients
Citric Acid Propylene Glycol Water Honey Propylparaben Sucralose Carboxymethylcellulose Sodium Glycerin Methylparaben

Identifiers & Packaging

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

Description

Active Ingredients ( in Each 5 ml) Purposes Dextromethorphan HBr, 10 mg ------------------------Cough Suppresant Guaifenesin, 100 mg --------------------------------------Expectorant


Medication Information

Description

Active Ingredients ( in Each 5 ml) Purposes Dextromethorphan HBr, 10 mg ------------------------Cough Suppresant Guaifenesin, 100 mg --------------------------------------Expectorant

Uses

Uses

Uses

Temporary relieves:

Cough due to minor throat and bronchial irritation associated with the common cold or inhaled irritants, the intensity of coughing , the impulse to cough to help your child get to sleep, helps loosen phlegm ( mucus) and thin bronchial secretions to make cough more productive

Section 51945-4

Children 4-12

Alcohol free, Dye free, Non-drowsy

True source certified honey

Children's Giltuss Honey

Cough & Chest Congestion

Cough & cold, chest congestion, liquifies and loosen phlegm and mucus

Honey lemon flavor

4 floz 118 ml

Stop Use

Stop use and ask a doctor if

cough lasts for more than 7 days , come back, or is accompanied by fever, rash or persistent headache. These could be signs of serious condition.

Warnings

Warnings

Do not use

If your child is now 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 don’t know is your prescription drug contains and MAOI, ask a doctor or pharmacist before taking this product.

Directions

Directions

Do not take more than 6 doses in any 24 hours period

use enclosed dosing cup

Keep dosage cup for use with this product

ml= milliliters

children under 4 years of age Consult a doctor

children 4 to under 6 years of age 2.5 ml every 4 hours

children 6 to under 12 years of age 5 ml every 4 hours

Adults and children 12 years & over 10 ml every 4 hours

Other Information

Other information

Store at room temperature 15-30 °C (59° -86 ° F)

Close cap tightly

SAVE CARTON FOR COMPLETE DRUG FACTS

Active Ingredients

Active Ingredients ( in Each 5 ml) Purposes

Dextromethorphan HBr, 10 mg ------------------------Cough Suppresant

Guaifenesin, 100 mg --------------------------------------Expectorant

Inactive Ingredients

Inactive ingredients

Carboxymethylcellulose sodium, citric acid, glycerin, natural and artificial flavor, natural grade A honey, methylparaben, propylene glycol, propylparaben, purified water,sucralose

Questions Or Comments?

Questions or comments?

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

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

Indication and Usage Section

Indication and usage section

Do not take more than 6 doses in any 24 hours period

use enclosed dosing cup

Keep dosage cup for use with this product

ml= milliliters

children under 4 years of age Consult a doctor

children 4 to under 6 years of age 2.5 ml every 4 hours

children 6 to under 12 years of age 5 ml every 4 hours

Adults and children 12 years & over 10 ml every 4 hours

Keep Out of Reach of Children

Keep out of reach of children. In case of accidental overdose, get medical or professional help or contact a Poisson Control center immediately

Ask A Doctor Before Use If the Child Has

Warnings

Ask a doctor before use if your child has, cough that occurs with too much phlegm (mucus) , a persistent or chronic cough as occurs with asthma.


Structured Label Content

Uses

Uses

Uses

Temporary relieves:

Cough due to minor throat and bronchial irritation associated with the common cold or inhaled irritants, the intensity of coughing , the impulse to cough to help your child get to sleep, helps loosen phlegm ( mucus) and thin bronchial secretions to make cough more productive

Section 51945-4 (51945-4)

Children 4-12

Alcohol free, Dye free, Non-drowsy

True source certified honey

Children's Giltuss Honey

Cough & Chest Congestion

Cough & cold, chest congestion, liquifies and loosen phlegm and mucus

Honey lemon flavor

4 floz 118 ml

Stop Use (Stop use)

Stop use and ask a doctor if

cough lasts for more than 7 days , come back, or is accompanied by fever, rash or persistent headache. These could be signs of serious condition.

Warnings (warnings)

Warnings

Do not use

If your child is now 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 don’t know is your prescription drug contains and MAOI, ask a doctor or pharmacist before taking this product.

Directions

Directions

Do not take more than 6 doses in any 24 hours period

use enclosed dosing cup

Keep dosage cup for use with this product

ml= milliliters

children under 4 years of age Consult a doctor

children 4 to under 6 years of age 2.5 ml every 4 hours

children 6 to under 12 years of age 5 ml every 4 hours

Adults and children 12 years & over 10 ml every 4 hours

Other Information (Other information)

Other information

Store at room temperature 15-30 °C (59° -86 ° F)

Close cap tightly

SAVE CARTON FOR COMPLETE DRUG FACTS

Active Ingredients

Active Ingredients ( in Each 5 ml) Purposes

Dextromethorphan HBr, 10 mg ------------------------Cough Suppresant

Guaifenesin, 100 mg --------------------------------------Expectorant

Inactive Ingredients (Inactive ingredients)

Inactive ingredients

Carboxymethylcellulose sodium, citric acid, glycerin, natural and artificial flavor, natural grade A honey, methylparaben, propylene glycol, propylparaben, purified water,sucralose

Questions Or Comments? (Questions or comments?)

Questions or comments?

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

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

Indication and Usage Section (Indication and usage section)

Indication and usage section

Do not take more than 6 doses in any 24 hours period

use enclosed dosing cup

Keep dosage cup for use with this product

ml= milliliters

children under 4 years of age Consult a doctor

children 4 to under 6 years of age 2.5 ml every 4 hours

children 6 to under 12 years of age 5 ml every 4 hours

Adults and children 12 years & over 10 ml every 4 hours

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children. In case of accidental overdose, get medical or professional help or contact a Poisson Control center immediately

Ask A Doctor Before Use If the Child Has (Ask a doctor before use if the child has)

Warnings

Ask a doctor before use if your child has, cough that occurs with too much phlegm (mucus) , a persistent or chronic cough as occurs with asthma.


Advanced Ingredient Data


Raw Label Data

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