Dosage & Administration
Directions:
■ follow dosage below or use as directed by a physician
■ do not take more than 6 doses in any 24-hour period
Guaifenesin And Dextromethorphan Hbr
FDA Label NDC 84447-102
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Belleview Biosciences for the product Guaifenesin And Dextromethorphan Hbr (NDC 84447-102). 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 dosage & administration, warnings, inactive ingredient, indications & usage, otc - keep out of reach of children, otc - purpose, otc - active ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Warnings
Warnings: Do not use if you are now taking a prescription monoamine oxidase inhibitor (MADI)
(certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease),or for 2
weeks after stopping the MADI drug.If you do not know if your
prescription drug contains an MAOI; ask a doctor or pharmacist before taking this product.t
Ask a doctor before use if you have
■ cough that occurs with too much phlegm (mucus)
■ cough that lasts or is chronic, such as occurs with smoking, asthma,
chronic bronchitis, or emphysema
Stop use and ask doctor if
■cough lasts more than 7 days., comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
■you are hypersensitive to any of the ingredients.
If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Inactive Ingredient
Inactive Ingredients: Citric Acid, Flavor, Methylparaben, Monoammonium Glycyrrhizinate, Potassium Citrate, Propylene Glycol, Propylparaben, Purified Water, Sorbitol, Sucralose
Indications & Usage
Uses:
■ helps loosen phlegm(mucus) and thin bronchial secretions to make coughs more productive
■ temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get
medical help or contact a Poison Control Center right away.
Otc - Purpose
Purpose:
Cough Suppressant and Expectorant
Otc - Active Ingredient
Active Ingredient (in each 5 mL tsp)
Dextromethorphan HBr 10mg
Guaifenesin 100mg
Package Label.Principal Display Panel
NDC 84447-102-01
Guaifenesin/Dextromethorphan Oral Solution
Guaifenesin 100mg/5ml
Dextromethoprhan 10mg/5ml
PLEASE HANDLE CAREFULLY
Inactive Ingredients: Citric Acid, Flavor, Methylparaben, Monoammonium Glycyrrhizinate, Potassium Citrate, Propylene Glycol, Propylparaben, Purified Water, Sorbitol, Sucralose
**Sugar, Alcohol, Gluten and Dye Free**
CAUTION:
FOR REPACKAGING ONLY
Store at controlled room temperature 15°-30°C (59°- 86°F)
* Please review the disclaimer below.
