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Drug Facts
Maxi-tuss Cd
FDA Label NDC 58605-303
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 Cd (NDC 58605-303). 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, when using this product, stop use and ask a doctor if, 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 |
|---|---|
| Chlorpheniramine Maleate 4 mg | Antihistamine |
| Codeine Phosphate 12 mg | Cough Suppressant |
| Phenylephrine HCI 10 mg | Nasal Decongestant |
Uses
temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
- cough due to minor throat and bronchial irritation
- runny nose
- sneezing
- itching of the nose or throat
- itchy, watery eyes
- nasal congestion
- reduces swelling of nasal passages
- calms the cough control center and relieves coughing
Warnings
- Do not exceed recommended dosage.
- 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.
- Adults and children who have a chronic pulmonary disease or shortness of breath, or children who are taking other drugs, should not take this product unless directed by a doctor.
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
- a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm
- 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
Ask a doctor before use if you are taking sedatives or tranquilizers
When Using This Product
- excitability may occur, especially in children
- may cause marked drowsiness
- alcohol, sedatives and tranquilizers may increase drowsiness
- avoid alcoholic beverages
- use caution when driving a motor vehicle or operating machinery
- may cause or aggravate constipation
Stop Use And Ask A Doctor If
- nervousness, dizziness, or sleeplessness occur
- if symptoms do not improve within 7 days or are accompanied by fever, consult a doctor
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: | 1 teaspoonful every 4 hours, not to exceed 6 teaspoonfuls in 24 hours, or as directed by a doctor |
| Children 6 to under 12 years of age: | ½ teaspoonful every 4 hours, not to exceed 3 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)
Inactive Ingredients
Citric acid, flavor, methylparaben, potassium citrate, potassium sorbate, propylparaben, propylene glycol, purified water, sorbitol, sucralose
Questions Or Comments?
Call (352) 754-8587
Principal Display Panel - 473 Ml Bottle Label
NDC 58605-303-16
Maxi-Tuss CD
Antihistamine ◾ Cough Suppressant
Nasal Decongestant
Each teaspoonful (5 mL) contains:
Chlorpheniramine Maleate 4 mg
Codeine Phosphate 12 mg
Phenylephrine HCl 10 mg
Grape Flavor
Alcohol Free ◾ Gluten Free ◾ Sugar Free
Caution: For manufacturing, processing, or
repackaging. This is a bulk container; not
intended for household use.
Tamper evident by foil seal under cap.
Do not use if foil seal is broken or missing.
16 fl oz (473 mL)
Principal Display Panel (473 mL Bottle Label)
* Please review the disclaimer below.
