MAXI-TUSS CD- chlorpheniramine maleate, codeine phosphate, and phenylephrine hydrochloride liquid 
MCR American Pharmaceuticals, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Maxi-Tuss CD

Drug Facts

Active Ingredients (in each 5 mL teaspoonful)Purpose
Chlorpheniramine Maleate 4 mgAntihistamine
Codeine Phosphate 10 mgCough Suppressant
Phenylephrine HCl 10 mgNasal Decongestant

Uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

Warnings

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

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.

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

CV

Each teaspoonful (5 mL) contains:
Chlorpheniramine Maleate 4 mg
Codeine Phosphate 10 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.

Lot:
Exp Date:

16 fl oz (473 mL)

Principal Display Panel - 473 mL Bottle Label
MAXI-TUSS CD 
chlorpheniramine maleate, codeine phosphate, and phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58605-303
Route of AdministrationORALDEA ScheduleCV    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE4 mg  in 5 mL
CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J) CODEINE PHOSPHATE10 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Methylparaben (UNII: A2I8C7HI9T)  
Potassium Citrate (UNII: EE90ONI6FF)  
Potassium Sorbate (UNII: 1VPU26JZZ4)  
Propylparaben (UNII: Z8IX2SC1OH)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Water (UNII: 059QF0KO0R)  
Sorbitol (UNII: 506T60A25R)  
Sucralose (UNII: 96K6UQ3ZD4)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58605-303-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/01/2018
2NDC:58605-303-1010 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/01/2018
Labeler - MCR American Pharmaceuticals, Inc. (783383011)
Establishment
NameAddressID/FEIBusiness Operations
MCR American Pharmaceuticals, Inc.783383011MANUFACTURE(58605-303)

Revised: 8/2019
Document Id: 9daf272d-ba0b-4f84-892b-0dc6e6f1abbd
Set id: e03294a3-1b3e-4d24-ac35-eca00a19db3d
Version: 4
Effective Time: 20190821
 
MCR American Pharmaceuticals, Inc.