FDA Label for Maximum Strength-cough And Chest Congestion Dm
View Indications, Usage & Precautions
Maximum Strength-cough And Chest Congestion Dm Product Label
The following document was submitted to the FDA by the labeler of this product Humanwell Puracap Pharmaceutical (wuhan) Co., Ltd.. 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
Active Ingredient (In Each Softgel)
Dextromethorphan HBr, USP 10 mg
Guaifenesin, USP 200 mg
Purpose
Cough suppressant
Expectorant
Uses
- temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
- helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
Do Not Use If
you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Stop Use And Ask A Doctor If
cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
Directions
• do not take more than 12 softgels in any 24-hour period
• this adult product is not intended for use in children under 12 years of age
| age | dose |
adults and children 12 years and over | 2 softgels every 4 hours |
children under 12 years | do not use |
Other Information
• store at room temperature 15-30°C (59-86°F)
• avoid excessive heat above 40°C (104°F)
Inactive Ingredients
FD&C Red #40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special and white edible ink
Manufactured by:
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.
Wuhan, Hubei
430206, China
Principal Display Panel - Shipping Label
Maximum Strength-Cough and Chest Congestion DM Liquid Filled Capsules
Quantity : 4000 Capsules
NDC. No : 53345-034-01
IMPORTANT:
- Inspect immediately upon receipt.
- This is a bulk shipment, intended for further processing only.
- Protect from heat, humidity, and light. Do not refrigerate.
- Store at 15-30°C (59-86°F)
CAUTION : FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING
* Please review the disclaimer below.