FDA Label for Guaiasorb DM
View Indications, Usage & Precautions
Guaiasorb DM Product Label
The following document was submitted to the FDA by the labeler of this product Geri-care Pharmaceuticals, Corp. 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.
Otc - Active Ingredient
Active ingredients (per 5 mL teaspoonful)
Dextromethorphan HBr 10 mg
Guaifenesin 100 mg
Otc - Purpose
Purpose
- cough suppressant
- expectorant
Indications & Usage
Uses
- temporarily relieves cough due to minor throat and bronchial irritation
- helps loosen phlegm mucus
- helps thin bronchial secretions to make coughs more productive
Warnings
Warnings
Do not use if you are now taking 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.
Ask a doctor before use if you have
- a cough with too much phlegm (mucus)
- a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema.
Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or headache that lasts. These could be signs of a serious condition
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
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.
Dosage & Administration
Directions
- do not exceed recommended dose
- take every 4 hours as needed, or as directed by a doctor
- do not take more than 6 doses in 24 hours
| Adults and children 12 years and over | 2 teaspoonfuls (10 mL) |
| Children under 12 years | Do not use |
Inactive Ingredient
Inactive ingreadients artificial and natural cherry flavor, citric acid, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose
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