Giltuss Allergy Plus Cough & Congestion

Giltuss Allergy Plus Cough & Congestion
SPL v1
SPL
SPL Set ID 3fa0b3be-2124-ed1d-e063-6294a90aaf48
Route
ORAL
Published
Effective Date 2018-10-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (20 mg) Phenylephrine (10 mg) Chlorpheniramine (4 mg)
Inactive Ingredients
Water Sucralose Propylparaben Citric Acid Methylparaben Glycerin

Identifiers & Packaging

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

Description

Active ingredients (in each 10 m) Purposes Chlorpheniramine maleate, USP 4 mg -------------------------------Antihistamine Dextromethorphan HBr, USP 20 mg -----------------------------------Cough supressant Phenylephrine HCl, USP 10 mg -----------------------------------------Nasal descongestant


Medication Information

Description

Active ingredients (in each 10 m) Purposes Chlorpheniramine maleate, USP 4 mg -------------------------------Antihistamine Dextromethorphan HBr, USP 20 mg -----------------------------------Cough supressant Phenylephrine HCl, USP 10 mg -----------------------------------------Nasal descongestant

Uses

Uses

Temporary relieves:

Cough due to minor throat and bronchial irritation associated 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

Section 51945-4

Maximum strength

Giltuss Allergy Plus

Cough & Congestion

Alcohol free, Sodium free, sugar free, dye free

Sneezing, runny nose, itchy and watery eyes, cough, stuffy nose, sinus pressure

Tutti Frutti flavor

4 floz 118 ml

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

Adults and children 12 years & over 10 ml every 4 to 6 hours

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

Children under 6 years of age Consult a doctor

hildren under 6 years of age Consult a doctor

Ask A Doctor

Ask a doctor before use if you have:

heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to an enlarged prostate unless directed by a doctor, a cough with too much phlegm (mucus), a persistent or chronic cough

as occurs with smoking, asthma, chronic bronchitis, or emphysema

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 10 m) Purposes

Chlorpheniramine maleate, USP 4 mg -------------------------------Antihistamine

Dextromethorphan HBr, USP 20 mg -----------------------------------Cough supressant

Phenylephrine HCl, USP 10 mg -----------------------------------------Nasal descongestant

Inactive Ingredients

Inactive Ingredients

Citric Acid, flavor, glycerin, methylparaben, propylparaben, purified water and 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

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

Adults and children 12 years & over 10 ml every 4 to 6 hours

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

Children under 6 years of age Consult a doctor

Stop Use and Ask A Doctor If

Stop use and ask a doctor if

if you get nervous, dizzy, or sleepless, symptoms do not get better within 7 days or are accompanied by fever, cough lasts more than 7 days, comeback, or is accompanied by fever,rash, or persistent headache

These could be signs of a serious condition.

If Pregnant Or Breast Feeding

If pregnant 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 Poisson Control center immediately

Keep Out of Reach of Children Section

keep out of reach of children section

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

Ak A Doctor Or Pharmacist Before Use It

As a doctor or pharmacist before use if you ar etaking any other oral nasal descongestant or stimulant, sedatives, tranquilizer, and drugs used for depression, especially momoamine oxidase inhibitors ( MAOI)


Structured Label Content

Uses

Uses

Temporary relieves:

Cough due to minor throat and bronchial irritation associated 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

Section 51945-4 (51945-4)

Maximum strength

Giltuss Allergy Plus

Cough & Congestion

Alcohol free, Sodium free, sugar free, dye free

Sneezing, runny nose, itchy and watery eyes, cough, stuffy nose, sinus pressure

Tutti Frutti flavor

4 floz 118 ml

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

Adults and children 12 years & over 10 ml every 4 to 6 hours

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

Children under 6 years of age Consult a doctor

hildren 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, thyroid disease, diabetes, or difficulty in urination due to an enlarged prostate unless directed by a doctor, a cough with too much phlegm (mucus), a persistent or chronic cough

as occurs with smoking, asthma, chronic bronchitis, or emphysema

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)

Active ingredients (in each 10 m) Purposes

Chlorpheniramine maleate, USP 4 mg -------------------------------Antihistamine

Dextromethorphan HBr, USP 20 mg -----------------------------------Cough supressant

Phenylephrine HCl, USP 10 mg -----------------------------------------Nasal descongestant

Inactive Ingredients

Inactive Ingredients

Citric Acid, flavor, glycerin, methylparaben, propylparaben, purified water and 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)

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

Adults and children 12 years & over 10 ml every 4 to 6 hours

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

Children under 6 years of age Consult a doctor

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

Stop use and ask a doctor if

if you get nervous, dizzy, or sleepless, symptoms do not get better within 7 days or are accompanied by fever, cough lasts more than 7 days, comeback, or is accompanied by fever,rash, or persistent headache

These could be signs of a serious condition.

If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

If pregnant 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 Poisson Control center immediately

Keep Out of Reach of Children Section (keep out of reach of children section)

keep out of reach of children section

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

Ak A Doctor Or Pharmacist Before Use It (Ak a doctor or pharmacist before use it)

As a doctor or pharmacist before use if you ar etaking any other oral nasal descongestant or stimulant, sedatives, tranquilizer, and drugs used for depression, especially momoamine oxidase inhibitors ( MAOI)


Advanced Ingredient Data


Raw Label Data

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