FDA Label for Chest Congestion
View Indications, Usage & Precautions
Chest Congestion Product Label
The following document was submitted to the FDA by the labeler of this product Accudial Pharmaceutical, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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 6 | ½ TSP to 1 TSP |
| 6 to under 12 | 1 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)
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