FDA Label for Maxi-tuss Gmx
View Indications, Usage & Precautions
Maxi-tuss Gmx Product Label
The following document was submitted to the FDA by the labeler of this product Mcr American Pharmaceuticals, 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
Otc - Purpose
| Active Ingredients (in each 5 mL teaspoonful) | Purpose |
|---|---|
| Dextromethorphan HBr 10 mg | Cough Suppressant |
| Guaifenesin 200 mg | Expectorant |
Uses
temporarily relieves
- cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
- the intensity of coughing
- the impulse to cough to help you get to sleep
Warnings
Do not exceed recommended dosage.
Do Not Use This Product
- 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
Ask A Doctor Before Use If You Have
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
- cough that occurs with too much phlegm (mucus)
Otc - Stop Use
Stop use and ask a doctor if
- cough lasts more than 7 days, comes back, or occurs with 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 accidental overdose, seek professional help or contact a Poison Control Center immediately.
Directions
Do not exceed recommended dosage.
| Adults and children 12 years of age and over: | 2 teaspoonfuls (10 mL) every 4 hours, not to exceed 12 teaspoonfuls in 24 hours or as directed by a doctor |
| Children 6 to under 12 years of age: | 1 teaspoonful (5 mL) every 4 hours, not to exceed 6 teaspoonfuls in 24 hours or as directed by a doctor |
| Children under 6 years of age: | Consult a physician |
Other Information
Store at 59°-86°F (15°-30°C) [see USP Controlled Room Temperature]
Inactive Ingredients
Cherry flavor, citric acid, methylparaben, monoammonium glycyrrhizinate, potassium citrate, propylparaben, propylene glycol, purified water, sorbitol, sucralose
Questions Or Comments?
Call 352.754.8587
Principal Display Panel - 473 Ml Bottle Label
NDC 58605-312-16
Maxi-Tuss GMX
Cough Suppressant ■ Expectorant
Sugar Free ■ Alcohol Free ■ Dye Free
Each teaspoonful (5 mL) for oral administration
contains:
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Cherry Flavor
Tamper evident by foil seal under cap.
Do not use if foil seal is broken or missing.
Manufactured for:
MCR American Pharmaceuticals, Inc.
Brooksville, FL 34604
16 fl oz (473 mL)
* Please review the disclaimer below.