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

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.

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

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

Other Information

Other information

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

Close cap tightly

SAVE CARTON FOR COMPLETE DRUG FACTS

Inactive Ingredients

Inactive Ingredients

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

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

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

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

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

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

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.

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

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

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

Inactive Ingredients

Inactive Ingredients

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

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

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

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

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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