Label: CHEST CONGESTION- guaifenesin solution
- NDC Code(s): 45014-163-04
- Packager: Accudial Pharmaceutical, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated February 6, 2013
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- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 5 mL = 1 teaspoon)
Guaifenesin, USP 100 mgClose
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.Close
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.
- 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
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
- each teaspoon contains: sodium 3 mg
- store between 20°-25°C (68°-77°F)
- tamper evident: do not use if foil seal over the mouth of the bottle is torn, broken, or missing.
- 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.Close
- SPL UNCLASSIFIED SECTION
Distributed by: AccuDial® Pharmaceutical, Inc.Close
Palm Beach Gardens, FL 33408
- PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton
Oral Solution Expectorant
Relieves Chest Congestion
Thins & Loosens Mucus
For Ages 4 yrs to under 12 yrs
Mucinex® For Kids
4 FL. OZ. (118 mL)
- INGREDIENTS AND APPEARANCE
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)