CHEST CONGESTION- guaifenesin liquid 
Accudial Pharmaceutical, Inc.

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.

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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

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

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

Principal Display Panel - 118 mL Carton
CHEST CONGESTION 
guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45014-150
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Caramel (UNII: T9D99G2B1R)  
Citric Acid Monohydrate (UNII: 2968PHW8QP)  
Corn Syrup (UNII: 9G5L16BK6N)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Glycerin (UNII: PDC6A3C0OX)  
Menthol (UNII: L7T10EIP3A)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Water (UNII: 059QF0KO0R)  
Sodium Benzoate (UNII: OJ245FE5EU)  
Saccharin Sodium (UNII: SB8ZUX40TY)  
Product Characteristics
ColorRED (Reddish-Pink) , PINKScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
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
Document Id: f0ffa4f3-7a9c-44ed-a4c1-cba9af870345
Set id: 6ab51aca-4ee8-401b-a0db-746dcde92517
Version: 2
Effective Time: 20091015
 
Accudial Pharmaceutical, Inc.