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Drug Facts
Maxi-tuss Pe
FDA Label NDC 58605-306
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Mcr American Pharmaceuticals, Inc. for the product Maxi-tuss Pe (NDC 58605-306). 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 other, otc - purpose, uses, warnings, do not take this product, otc - ask doctor, otc - ask doctor/pharmacist, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active Ingredients (in each 5 mL teaspoonful) | Purpose |
|---|---|
| Brompheniramine Maleate 2 mg | Antihistamine |
| Phenylephrine HCl 5 mg | Nasal Decongestant |
Uses
temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other respiratory allergies:
- runny nose
- sneezing
- itching of the nose or throat
- itchy, watery eyes
- nasal congestion
- reduces swelling of nasal passages
Warnings
Do not exceed recommended dosage.
Do Not Take 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.
Otc - Ask Doctor
Ask a doctor before use if you have
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- heart disease
- high blood pressure
- thyroid disease
- diabetes mellitus
- difficulty in urination due to enlargement of the prostate gland
Otc - Ask Doctor/Pharmacist
Ask a doctor before use if you are taking sedatives or tranquilizers.
When Using This Product
- excitability may occur, especially in children
- may cause drowsiness
- sedatives and tranquilizers may increase drowsiness effect
- avoid alcoholic beverages
- use caution when driving a motor vehicle or operating machinery
Stop Use And Ask Doctor If
- nervousness, dizziness, or sleeplessness occur
- If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor
- new symptoms occur
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, 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 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 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 |
Other Information
Store at 59° - 86° F (15° - 30° C) [see USP for Controlled Room Temperature].
Inactive Ingredients
Bubblegum flavor, citric acid, FD&C Red #40, methylparaben, potassium citrate, propylene glycol, propylparaben, purified water, sorbitol, sucralose
Questions Or Comments?
Call 352.754.8587
Principal Display Panel - 473 Ml Bottle Label
NDC 58605-306-16
Maxi-Tuss PE
Antihistamine • Nasal Decongestant
Sugar Free • Alcohol Free
• Gluten Free
Each teaspoonful (5 mL)
for oral administration contains:
Brompheniramine Maleate 2 mg
Phenylephrine HCl 5 mg
Bubblegum 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
16oz. (473 mL)
Principal Display Panel (473 mL Bottle Label)
* Please review the disclaimer below.
