MAXI-TUSS JR- dextromethorphan hydrobromide 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 Jr

Drug Facts

Active Ingredients (in each 5 mL teaspoonful)Purpose
Dextromethorphan HBr 5 mgCough Suppressant
Phenylephrine HCl 2.5 mgNasal Decongestant

Uses

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

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: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
MAXI-TUSS JR 
dextromethorphan hydrobromide and phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58605-308
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide5 mg  in 5 mL
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride2.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Methylparaben (UNII: A2I8C7HI9T)  
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
Potassium Citrate (UNII: EE90ONI6FF)  
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:58605-308-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34108/01/2020
Labeler - MCR American Pharmaceuticals, Inc. (783383011)
Establishment
NameAddressID/FEIBusiness Operations
MCR American Pharmaceuticals, Inc.783383011MANUFACTURE(58605-308)

Revised: 6/2020
Document Id: a3c46b8a-f10a-4a24-abc7-223a681964b4
Set id: 61d0d0fe-d8b8-45ee-847d-c1b547542fab
Version: 1
Effective Time: 20200624
 
MCR American Pharmaceuticals, Inc.