Giltuss Ex Expectorant

Giltuss Ex Expectorant
SPL v1
SPL
SPL Set ID 3f67ac3d-1503-3418-e063-6394a90a938f
Route
ORAL
Published
Effective Date 2020-06-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (400 mg)
Inactive Ingredients
Sucralose Water Citric Acid Sodium Citrate Propylparaben Glycerin Methylparaben Propylene Glycol

Identifiers & Packaging

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

Description

Active Ingredients Guafenesin, 400 mg


Medication Information

Description

Active Ingredients Guafenesin, 400 mg

Uses

Purpose

Expectorant

Uses

  • helps loosen phlegm ( mucus) and thin bronchial secretions to rid the bronchial passageway of bothersome mucus and make coughs more productive

Section 51945-4

Maximun strength Giltuss EX Expectorant

Guafenesin 400 mg

Alcohol free, sugar free, Dye free, Non-Drowsy

Chest congestion, Phlegm & Mucus

Tutti Frutti Flavor

4 floz 118 ml

Stop Use

Stop use and ask a doctor if cough lasts for more than 1 week, tends to recur or is accompanied by fever, rash or persistent headache. A persistant cough may be a sign of a serious condition

Warnings

Warnings

  • Ask a doctor before use if you have , cough that occurs with too much phlegm ( mucus) , persistent or chronic cough such occurs with smoking, asthma, or chronic bronchitis or emphysema
Directions

Directions

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

Use enclosed dosing cup

Keep dosing cup for use this product

ml= mililiters

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

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

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

children under 4 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

Active Ingredients

Active Ingredients

Guafenesin, 400 mg

Inactive Ingredients

Inactive Ingredients

Citric acid, glycerin, methylparaben,natural and artificial flavor, polyethylene glycol, propylparaben, purified water, sodium citrate,

sucralose

Questions and Comments

Questions and 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 User Section

Indication and usage

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

Keep sosage cup for use with this product

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

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

Children 4 to under 6 years of age 2.5ml ever 4 hours

Children under 4 years of age Consult a doctor

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 Poison Control center immediately

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


Structured Label Content

Uses

Purpose

Expectorant

Uses

  • helps loosen phlegm ( mucus) and thin bronchial secretions to rid the bronchial passageway of bothersome mucus and make coughs more productive

Section 51945-4 (51945-4)

Maximun strength Giltuss EX Expectorant

Guafenesin 400 mg

Alcohol free, sugar free, Dye free, Non-Drowsy

Chest congestion, Phlegm & Mucus

Tutti Frutti Flavor

4 floz 118 ml

Stop Use

Stop use and ask a doctor if cough lasts for more than 1 week, tends to recur or is accompanied by fever, rash or persistent headache. A persistant cough may be a sign of a serious condition

Warnings

Warnings

  • Ask a doctor before use if you have , cough that occurs with too much phlegm ( mucus) , persistent or chronic cough such occurs with smoking, asthma, or chronic bronchitis or emphysema
Directions

Directions

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

Use enclosed dosing cup

Keep dosing cup for use this product

ml= mililiters

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

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

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

children under 4 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

Active Ingredients

Active Ingredients

Guafenesin, 400 mg

Inactive Ingredients

Inactive Ingredients

Citric acid, glycerin, methylparaben,natural and artificial flavor, polyethylene glycol, propylparaben, purified water, sodium citrate,

sucralose

Questions and Comments (Questions and comments)

Questions and 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 User Section (Indication and user section)

Indication and usage

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

Keep sosage cup for use with this product

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

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

Children 4 to under 6 years of age 2.5ml ever 4 hours

Children under 4 years of age Consult a doctor

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 Poison Control center immediately

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


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