CHEST CONGESTION- guaifenesin solution 
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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Chest Congestion

Drug Facts

Active ingredient (in each 5 mL = 1 teaspoon)

Guaifenesin, USP 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.

Ask a doctor before use if the child has a cough that occurs with too much phlegm (mucus) or persistant or chronic cough such as occurs with asthma.

Directions

  • may be given every 4 hours
  • do not use more than 6 times in 24 hours
  • use only enclosed dosing cup to dose this product. Do not use any other dosing device.

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.

Consult your pharmacist or health care provider for any appropriate, additional dosage delivery device necessary for use when a physician recommends a dose that is different than the doses that appear on the dosage delivery device that accompanies this product.

Age (yr)Dose (TSP)
TSP = teaspoon
under 4 yrs.ask a doctor
4 to under 6½ TSP to 1 TSP
6 to under 121 TSP to 2 TSP
or as directed by a doctor

Keep out of reach of children.

Overdose warning

Taking more than the recommended dose (overdose) may cause liver damage. In the case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Prompt medical attention is critical, even if you do not notice any signs or symptoms.

Other information

Inactive ingredients

artificial flavor, citric acid, corn syrup FD&C blue #1, D&C red #33, glycerin, purified water sodium benzoate, sodium saccharin, sucralose, xanthan gum.

Questions?

877-434-2036

Distributed by: AccuDial® Pharmaceutical, Inc.
Palm Beach Gardens, FL 33408

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

ACCUDIAL®
Children's
Chest
Congestion

Guaifenesin
Oral Solution Expectorant

Relieves Chest Congestion
Thins & Loosens Mucus

Earth-Friendly
Package!

For Ages 4 yrs to under 12 yrs

Tamper Evident

Compares to
Mucinex® For Kids

GRAPE
FLAVOR

NDC 45014-163-04
4 FL. OZ. (118 mL)

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton
CHEST CONGESTION 
guaifenesin solution
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:45014-163
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (Guaifenesin) Guaifenesin100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Citric Acid Monohydrate 
Corn Syrup 
FD&C Blue No. 1 
D&C Red No. 33 
Glycerin 
Water 
Sodium Benzoate 
Saccharin Sodium 
Sucralose 
Xanthan Gum 
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:45014-163-04118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34102/01/2013
Labeler - Accudial Pharmaceutical, Inc. (831999201)

Revised: 2/2013
Document Id: c7ba2caf-ed17-4171-b900-4d3e0155cdc4
Set id: 37c6ebc3-55fe-4158-a5d6-05c5b4bb5f50
Version: 1
Effective Time: 20130206
 
Accudial Pharmaceutical, Inc.