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Drug Facts
Maxi-tuss Jr
FDA Label NDC 58605-308
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 Jr (NDC 58605-308). 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 use this product, ask a doctor before use if you have, stop use and ask a doctor if, otc - pregnancy or breast feeding, 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 |
|---|---|
| Dextromethorphan HBr 5 mg | Cough Suppressant |
| Phenylephrine HCl 2.5 mg | Nasal Decongestant |
Uses
temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other respiratory allergies:
- cough due to minor throat and bronchial irritation as may occur with a cold
- nasal congestion due to a cold, hay fever or other upper respiratory allergies
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
- high blood pressure
- thyroid disease
- diabetes
- cough that occurs with too much phlegm (mucus)
- chronic cough that lasts or as occurs with asthma
- difficulty in urination due to enlargement of the prostate gland
- A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.
- Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.
Stop Use And Ask A Doctor If
- nervousness, dizziness, or sleeplessness occur
- symptoms do not improve within 7 days or are accompanied by fever
- new symptoms occur
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 24 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 12 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
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 58605-308-16
Maxi-Tuss Jr
Cough Suppressant ■ Nasal Decongestant
Sugar Free ■ Alcohol Free ■ Dye Free
Each teaspoonful (5 mL) for oral administration
contains:
Dextromethorphan HBr 5 mg
Phenylephrine HCl 2.5 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)
Principal Display Panel (473 mL Bottle Label)
* Please review the disclaimer below.
