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 6 ½ TSP to 1 TSP
6 to under 12 1 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 Type HUMAN OTC DRUG Item Code (Source) NDC:45014-163
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin 100 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
Citric Acid Monohydrate (UNII: 2968PHW8QP)  
Corn Syrup (UNII: 9G5L16BK6N)  
FD&C Blue No. 1 (UNII: H3R47K3TBD)  
D&C Red No. 33 (UNII: 9DBA0SBB0L)  
Glycerin (UNII: PDC6A3C0OX)  
Water (UNII: 059QF0KO0R)  
Sodium Benzoate (UNII: OJ245FE5EU)  
Saccharin Sodium (UNII: SB8ZUX40TY)  
Sucralose (UNII: 96K6UQ3ZD4)  
Xanthan Gum (UNII: TTV12P4NEE)  
Product Characteristics
Color PURPLE Score     
Shape Size
Flavor GRAPE Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:45014-163-04 118 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 02/01/2013
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.