Chest Congestion
FDA Label NDC 45014-163

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Accudial Pharmaceutical, Inc. for the product Chest Congestion (NDC 45014-163). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient (in each 5 ml = 1 teaspoon), purpose, uses, otc - ask doctor, directions, otc - stop use, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

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

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.

Otc - Ask Doctor

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.

Otc - Stop Use

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.

Otc - Ask Doctor/Pharmacist

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

Otc - Keep Out Of Reach Of Children

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

  • 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.

Questions?

877-434-2036

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)

Principal Display Panel (118 mL Bottle Carton)

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