Giltuss D

Giltuss D
SPL v1
SPL
SPL Set ID 3f17eefb-b625-b0f2-e063-6294a90afd4d
Route
ORAL
Published
Effective Date 2024-04-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenylephrine (10 mg) Chlorpheniramine (3.5 mg)
Inactive Ingredients
Citric Acid Methylparaben Propylene Glycol Sucralose Water Carboxymethylcellulose Sodium Glycerin Propylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-04-11

Description

Purposes Antihistamine Nasal decongestant Uses Temporary relieves these symptons due to hay fever ( allergy rhinitis) or other respiratory allergies: runny nose, sneezing, itchy, watery eyes, nasal congestion, itching of nose or throat, sinus congestion and pressure

Purpose

Purposes Antihistamine Nasal decongestant Uses Temporary relieves these symptons due to hay fever ( allergy rhinitis) or other respiratory allergies: runny nose, sneezing, itchy, watery eyes, nasal congestion, itching of nose or throat, sinus congestion and pressure


Medication Information

Purpose

Purposes Antihistamine Nasal decongestant Uses Temporary relieves these symptons due to hay fever ( allergy rhinitis) or other respiratory allergies: runny nose, sneezing, itchy, watery eyes, nasal congestion, itching of nose or throat, sinus congestion and pressure

Description

Purposes Antihistamine Nasal decongestant Uses Temporary relieves these symptons due to hay fever ( allergy rhinitis) or other respiratory allergies: runny nose, sneezing, itchy, watery eyes, nasal congestion, itching of nose or throat, sinus congestion and pressure

Section 51945-4

Giltuss D

Allergy & Congestion

Dye Free, preservative free, sodium free, sugar free

Sneezing, Runny Nose, Itchy & Water eyes, Itchy Throat or Nose, Sinus pressure, stuffy nose

Tutti Frutti Flavor

$ floz 118 ml

Section 55106-9

Chlorpheniramine maleate 3.5 mg

Phenilephryne HCl, 10 mg

Purposes

Purposes

Antihistamine

Nasal decongestant

Uses

Temporary relieves these symptons due to hay fever ( allergy rhinitis) or other respiratory allergies:

runny nose, sneezing, itchy, watery eyes, nasal congestion, itching of nose or throat, sinus congestion and pressure

Warnings

Warnings:

Do not use to sedate a child or to make a child sleepy, if you ar etaking a prescription monoamine oxidase inhibitor ( MAOI) ( certains 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Directions

Directions, not take more than 6 doses in any 24 hours period, use enclosed dosing cup, keep dosage cup for use with this product, ml= mililiter

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

Children 6 to under 12 years 5 ml every 4 hours

Children under 6 years Consult a doctor

When Using

When using this product, do not use more than directed, may cause drowsiness, avoid alcoholic beverages, alcohol, sedatives, and tranquilizers may increase drowsiness, avoid alcoholic drinks, be careful when driving a motor vehicle or operating machinery, exitability may occur, especially in children.

Ask A Doctor

Ask a doctor before use if you have:

Heart desease, high blood pressure, thyroid desease, diabetes, trouble urinating due to enlarged prostate gland, glaucoma, a breathing problem or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or ephysema

Stop Use Section

Stop use and ask a doctor if, if you get nervous, dizzy or sleepless, symptons do not get better witi

hin 7 days or are accompanied by fever

Other Information

Other information store at room temperature 15 - 30 oC (59-86 o F), close cap tightly, save carton for complete drug facts

Inactive Ingredients

Inactive Ingredients

Citric Acid, Flavor, Glycerin, Methylparaben, Propylene Glycol, Propylparaben, Purified water, Sodium Carboxymethylcellulose, Sucralose.

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

Ask A Doctor Or Pharmacist

Ask a doctor or pharmacist before use if you are, taking sedatives or tranquilizers

Pregnancy Or Breast Feeding

If Pregnancy or breast-feeding, ask a health professional before use. Keep out of reach of children. In case or overdose, get medical help or contact a Poisson Control Center right away ( 1-800-222-1222)

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= mililiter

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

Children 6 to under 12 years 5 ml every 4 hours

Children under 6 years Consult a doctor

Keep Out of Reach of Children.

Keep out of reach of children.

In case or overdose, get medical help or contact a Poison Control Center right away ( 1-800-222-1222)


Structured Label Content

Section 51945-4 (51945-4)

Giltuss D

Allergy & Congestion

Dye Free, preservative free, sodium free, sugar free

Sneezing, Runny Nose, Itchy & Water eyes, Itchy Throat or Nose, Sinus pressure, stuffy nose

Tutti Frutti Flavor

$ floz 118 ml

Section 55106-9 (55106-9)

Chlorpheniramine maleate 3.5 mg

Phenilephryne HCl, 10 mg

Purposes

Purposes

Antihistamine

Nasal decongestant

Uses

Temporary relieves these symptons due to hay fever ( allergy rhinitis) or other respiratory allergies:

runny nose, sneezing, itchy, watery eyes, nasal congestion, itching of nose or throat, sinus congestion and pressure

Warnings

Warnings:

Do not use to sedate a child or to make a child sleepy, if you ar etaking a prescription monoamine oxidase inhibitor ( MAOI) ( certains 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Directions

Directions, not take more than 6 doses in any 24 hours period, use enclosed dosing cup, keep dosage cup for use with this product, ml= mililiter

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

Children 6 to under 12 years 5 ml every 4 hours

Children under 6 years Consult a doctor

When Using (When using)

When using this product, do not use more than directed, may cause drowsiness, avoid alcoholic beverages, alcohol, sedatives, and tranquilizers may increase drowsiness, avoid alcoholic drinks, be careful when driving a motor vehicle or operating machinery, exitability may occur, especially in children.

Ask A Doctor (Ask a doctor)

Ask a doctor before use if you have:

Heart desease, high blood pressure, thyroid desease, diabetes, trouble urinating due to enlarged prostate gland, glaucoma, a breathing problem or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or ephysema

Stop Use Section (Stop use section)

Stop use and ask a doctor if, if you get nervous, dizzy or sleepless, symptons do not get better witi

hin 7 days or are accompanied by fever

Other Information (Other information)

Other information store at room temperature 15 - 30 oC (59-86 o F), close cap tightly, save carton for complete drug facts

Inactive Ingredients (Inactive ingredients)

Inactive Ingredients

Citric Acid, Flavor, Glycerin, Methylparaben, Propylene Glycol, Propylparaben, Purified water, Sodium Carboxymethylcellulose, 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

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

Ask a doctor or pharmacist before use if you are, taking sedatives or tranquilizers

Pregnancy Or Breast Feeding (Pregnancy or breast-feeding)

If Pregnancy or breast-feeding, ask a health professional before use. Keep out of reach of children. In case or overdose, get medical help or contact a Poisson Control Center right away ( 1-800-222-1222)

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= mililiter

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

Children 6 to under 12 years 5 ml every 4 hours

Children under 6 years Consult a doctor

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

Keep out of reach of children.

In case or overdose, get medical help or contact a Poison Control Center right away ( 1-800-222-1222)


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Raw Label Data

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