FDA Label for Maxi-tuss Cd

View Indications, Usage & Precautions

Maxi-tuss Cd 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
Chlorpheniramine Maleate 4 mgAntihistamine
Codeine Phosphate 12 mgCough Suppressant
Phenylephrine HCI 10 mgNasal 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)


* Please review the disclaimer below.