FDA Label for Maxi-tuss Pe Max
View Indications, Usage & Precautions
Maxi-tuss Pe Max 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
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 doctor |
Otc - Purpose
| Active Ingredients (in each 5 mL teaspoonful) | Purpose |
|---|---|
| Guaifenesin 100 mg | Expectorant |
| Phenylephrine HCl 5 mg | Nasal Decongestant |
Uses
temporarily relieves
- Nasal congestion due to the common cold
- Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
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
- heart disease
- thyroid disease
- high blood pressure
- diabetes
- difficulty in urination due to enlargement of the prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
- cough that occurs with too much phlegm (mucus)
Stop Use And Ask A Doctor If
- nervousness, dizziness, or sleeplessness occur
- 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.
Keep Out Of Reach Of Children.
In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.
Other Information
Store at 59°-86°F (15°-30°C) [see USP Controlled Room Temperature]
Inactive Ingredients
Citric acid, grape flavor, 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 58605-315-16
Maxi-Tuss PE Max
Expectorant ◾ Nasal Decongestant
Sugar Free ◾ Alcohol Free ◾ Dye Free
Each teaspoonful (5 mL) for oral administration
contains:
Guaifenesin 100 mg
Phenylephrine HCl 5 mg
Grape 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.