Giltuss Cough And Cold

Giltuss Cough And Cold
SPL v1
SPL
SPL Set ID 3f12ee8f-d1c6-d73a-e063-6394a90a9199
Route
ORAL
Published
Effective Date 2018-10-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (15 mg) Phenylephrine (10 mg) Guaifenesin (300 mg)
Inactive Ingredients
Propylene Glycol Hydroxyethylcellulose Sorbitol Solution Citric Acid Sucralose Methylparaben Water Glycerin Polyethylene Glycol, Unspecified Propylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-10-02

Description

Active Ingredients ( in each 5 mL) Dextromethorphan HBr , 15 mg Guaifenesin, 300 mg Phenylephryne HCl, 10 mg


Medication Information

Description

Active Ingredients ( in each 5 mL) Dextromethorphan HBr , 15 mg Guaifenesin, 300 mg Phenylephryne HCl, 10 mg

Section 55106-9

Active Ingredients ( in each 5 mL)

Dextromethorphan HBr , 15 mg

Guaifenesin, 300 mg

Phenylephryne HCl, 10 mg

Stop Use

Stop use and ask a doctor if, nervousness, dizziness, or sleeplessness occur, sympton do not get better within 7 days or are accompanied by fever, cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These can be signs of a serious condition.

Warnings

Warnings

Do not use if you are 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 dont know if your prescription drug contains and MAOI , ask a doctor or pharmacist before taking this product,

Questions

Questions

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

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

Directions

Directions, do not exceed recommended dosage, do not take more than 6 doses in any 24 hours period, keep dosing cup for use with this product, ml=mililiters.

Adults and children 12 years & over 5 ml every 4 hours

children 6 to under 12 years age 2.5 ml every 4 hours

children 4 to 6 years of age 1.25 ml every 4 hours

children under 6 years of age Consult a doctor

Ask A Doctor

Ask a doctor before use if you have, heart disease, high blood pressure, thryroid disease, diabetes, or difficulty in urination due to enlargement of the prostate unless directed by a doctor, cough with too much phlegm ( mucus), a persistent or chronic cough as occurs with smoking, asthma,chronic bronchitis, or ephysema

Principal Panel

maximun strength

Giltuss Cold & cold

Alcohol free

Sugar free

Dye free

Cough, Phlem & Stuffy nose

Non-drowsy

Cherry flavor

4 flox 118 ml

Other Information

Other information

Store at room temperature , between 15-30 oC

Keep thigtly closed

Save carton for complete drug facts

Inactive Ingredients

Purpouse Section & Uses

Cough supressant

Expectorant

Nasal Descongestant

Uses

temporary relieves cough due to minor throat and bronchial irritations as may occur with the common cold or inhaled irritants, helps loosen phlegm ( mucus) and thin bronchial secretions to make cough more productive, temporary relieves nasal congestion due to a cold.

Ask A Doctor Or Pharmacist

Ask a doctor o pharmacist before use if you are taking any other oral nasal decongestant or stimulant, sedatives , tranquilizer, and drugs used for depression, especially monoamine oxidase inhibitors (MAOI's)

Pregnancy Or Breast Feeding

Pregnancy or breast feeding, ask a health professional before use. Keep out of reach of children. In case of accidental overdose, get medical or professional help or contact a Poison Control Center immediatly.

Indication and Usage Section

Indication and usage section

Do not exceed recommended dosage, do not take more than 6 doses in any 24 hours period, keep dosing cup for use with this product, ml=mililiters.

Adults and children 12 years & over 5 ml every 4 hours

children 6 to under 12 years age 2.5 ml every 4 hours

children 4 to 6 years of age 1.25 ml every 4 hours

children under 6 years of age Consult a doctor

Keep Out of Reach of Children

Keep out of reach of children section

In case of accidental overdose, get medical or professional help or contact a Poison Control Center immediatly.


Structured Label Content

Section 55106-9 (55106-9)

Active Ingredients ( in each 5 mL)

Dextromethorphan HBr , 15 mg

Guaifenesin, 300 mg

Phenylephryne HCl, 10 mg

Stop Use (Stop use)

Stop use and ask a doctor if, nervousness, dizziness, or sleeplessness occur, sympton do not get better within 7 days or are accompanied by fever, cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These can be signs of a serious condition.

Warnings

Warnings

Do not use if you are 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 dont know if your prescription drug contains and MAOI , ask a doctor or pharmacist before taking this product,

Questions

Questions

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

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

Directions

Directions, do not exceed recommended dosage, do not take more than 6 doses in any 24 hours period, keep dosing cup for use with this product, ml=mililiters.

Adults and children 12 years & over 5 ml every 4 hours

children 6 to under 12 years age 2.5 ml every 4 hours

children 4 to 6 years of age 1.25 ml every 4 hours

children under 6 years of age Consult a doctor

Ask A Doctor (Ask a Doctor)

Ask a doctor before use if you have, heart disease, high blood pressure, thryroid disease, diabetes, or difficulty in urination due to enlargement of the prostate unless directed by a doctor, cough with too much phlegm ( mucus), a persistent or chronic cough as occurs with smoking, asthma,chronic bronchitis, or ephysema

Principal Panel (Principal panel)

maximun strength

Giltuss Cold & cold

Alcohol free

Sugar free

Dye free

Cough, Phlem & Stuffy nose

Non-drowsy

Cherry flavor

4 flox 118 ml

Other Information (other information)

Other information

Store at room temperature , between 15-30 oC

Keep thigtly closed

Save carton for complete drug facts

Inactive Ingredients

Purpouse Section & Uses

Cough supressant

Expectorant

Nasal Descongestant

Uses

temporary relieves cough due to minor throat and bronchial irritations as may occur with the common cold or inhaled irritants, helps loosen phlegm ( mucus) and thin bronchial secretions to make cough more productive, temporary relieves nasal congestion due to a cold.

Ask A Doctor Or Pharmacist (Ask a doctor or pharmacist)

Ask a doctor o pharmacist before use if you are taking any other oral nasal decongestant or stimulant, sedatives , tranquilizer, and drugs used for depression, especially monoamine oxidase inhibitors (MAOI's)

Pregnancy Or Breast Feeding (Pregnancy or breast feeding)

Pregnancy or breast feeding, ask a health professional before use. Keep out of reach of children. In case of accidental overdose, get medical or professional help or contact a Poison Control Center immediatly.

Indication and Usage Section (Indication and usage section)

Indication and usage section

Do not exceed recommended dosage, do not take more than 6 doses in any 24 hours period, keep dosing cup for use with this product, ml=mililiters.

Adults and children 12 years & over 5 ml every 4 hours

children 6 to under 12 years age 2.5 ml every 4 hours

children 4 to 6 years of age 1.25 ml every 4 hours

children under 6 years of age Consult a doctor

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

Keep out of reach of children section

In case of accidental overdose, get medical or professional help or contact a Poison Control Center immediatly.


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Raw Label Data

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