Childrens

Childrens
SPL v2
SPL
SPL Set ID 1daa3c05-eaeb-4219-a959-4959750a30a0
Route
ORAL
Published
Effective Date 2012-11-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (100 mg)
Inactive Ingredients
Acesulfame Potassium Anhydrous Citric Acid Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Maltitol Propylene Glycol Water Saccharin Sodium Sodium Benzoate Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: purple
Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-07-01

Description

Drug Facts

Purpose

Expectorant


Medication Information

Purpose

Expectorant

Description

Drug Facts

Uses

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

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

Directions
  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • mL = milliliter
Age Dose
children 6 years to under 12 years 5 mL – 10 mL

every 4 hours
children 4 years to under 6 years 2.5 mL – 5 mL

every 4 hours
children under 4 years do not use
Questions?

1-866-MUCINEX (1-866-682-4639)

You may also report side effects to this phone number.

Other Information
  • tamper evident: do not use if printed neckband on bottle cap is broken or missing
  • store between 20-25°C (68-77°F)
  • do not refrigerate
  • dosing cup provided
Inactive Ingredients

acesulfame potassium, anhydrous citric acid, FD&C blue #1, FD&C red #40, flavor, glycerin, maltitol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol, sucralose, xanthan gum

Active Ingredient (in Each 5 Ml)

Guaifenesin, USP 100 mg

Ask A Doctor Before Use If the Child Has
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with asthma
Principal Display Panel 118 Ml Bottle Carton

NDC 63824-280-64

Children's

Mucinex®

Chest

Congestion

Guaifenesin Oral Solution, USP

Expectorant

  • Chest Congestion
  • Breaks up Mucus
  • Alcohol-free

Grape

Flavor Liquid

4 FL OZ

(118 mL)


Structured Label Content

Uses

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

Purpose

Expectorant

Directions
  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • mL = milliliter
Age Dose
children 6 years to under 12 years 5 mL – 10 mL

every 4 hours
children 4 years to under 6 years 2.5 mL – 5 mL

every 4 hours
children under 4 years do not use
Questions?

1-866-MUCINEX (1-866-682-4639)

You may also report side effects to this phone number.

Other Information (Other information)
  • tamper evident: do not use if printed neckband on bottle cap is broken or missing
  • store between 20-25°C (68-77°F)
  • do not refrigerate
  • dosing cup provided
Inactive Ingredients (Inactive ingredients)

acesulfame potassium, anhydrous citric acid, FD&C blue #1, FD&C red #40, flavor, glycerin, maltitol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol, sucralose, xanthan gum

Active Ingredient (in Each 5 Ml) (Active ingredient (in each 5 mL))

Guaifenesin, USP 100 mg

Ask A Doctor Before Use If the Child Has (Ask a doctor before use if the child has)
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with asthma
Principal Display Panel 118 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton)

NDC 63824-280-64

Children's

Mucinex®

Chest

Congestion

Guaifenesin Oral Solution, USP

Expectorant

  • Chest Congestion
  • Breaks up Mucus
  • Alcohol-free

Grape

Flavor Liquid

4 FL OZ

(118 mL)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)