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Chest Congestion by Accudial Pharmaceutical, Inc.

Dosage form: liquid
Ingredients: Guaifenesin 100mg in 5mL
Labeler: Accudial Pharmaceutical, Inc.
NDC Code: 45014-150

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

CHILDREN'S
ACCUDIAL

CHEST CONGESTION

Drug Facts

Active ingredient (in each 5 mL tsp)

Guaifenesin 100 mg

Purpose

Expectorant

Uses

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

Warnings

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

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.

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

Directions
  • do not take more than 6 doses in any 24-hour period
  • to find right dose, use rotating bottle label to dose by weight; otherwise, use chart at right to dose by age
  • specifically designed for use with enclosed dosing spoon. Use only enclosed dosing spoon to dose this product.
    Do not use any other device
AgeDose
children 6 years to under 12 years5 mL to 10 mL or 1-2 teaspoonfuls every 4 hours
childen 4 years to under 6 years2.5 mL to 5 mL or 1/2-1 teaspoonful every 4 hours
children under 4 yearsdo not use

Other information
  • tamper evident: do not use if foil seal under bottle cap is broken or missing.
  • store between 20°-25°C (68°-77°F)

Inactive ingredients

caramel powder, citric acid, corn syrup, FD&C red no. 40, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sodium saccharin.

Questions?

877-434-2036

PRINCIPAL DISPLAY PANEL - 118 mL Carton

CHILDREN'S
ACCUDIAL

ROTATING DOSING LABEL

ACCURATE DOSING
BY WEIGHT

Guaifenesin
Oral Solution

Expectorant

RELIEVES
Chest Congestion
Thins & Loosens
Mucus

For Ages 4 to under 12

Alcohol Free

Compares to
Mucinex® For Kids!

MENTHOL
FLAVOR

4 FL. OZ.
(118 mL)

NDC 45014-150-04

Chest Congestion

CHEST CONGESTION 
guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45014-150
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (Guaifenesin) Guaifenesin100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Caramel 
Citric Acid Monohydrate 
Corn Syrup 
FD&C RED NO. 40 
Glycerin 
Menthol 
Propylene Glycol 
Water 
Sodium Benzoate 
Saccharin Sodium 
Product Characteristics
ColorRED (Reddish-Pink) , PINKScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:45014-150-04118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34110/26/2009
Labeler - Accudial Pharmaceutical, Inc. (831999201)

Revised: 10/2009
 
Accudial Pharmaceutical, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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