FATHER JOHNS COUGH MEDICINE PLUS- nasal decongestant liquid 
Humco Holding Group, 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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Private Label Father John's Medicine Plus

Each 30 mL (2 tablespoonfuls) contain:

Dextromethorphan HBr, 10mg

Phenylephrine HCl, 10mg

Chlorpheniramine Maleate, 4mg

Citric acid

FD&C Red #40

FD&C Blue #1

Glycerin

Purified water

Sodium benzoate

Sodium chloride

Sodium citrate

Sodium saccharin

Sucrose

DO NOT take more than 12 tablespoonfuls in 24 hours

Adults and Children 12 years and older: take 2 tablespoons every 4 hours

Children under 12 years old: ask a doctor

For temporarily relief of couch and allergy symptoms, including coughing, nasal congestion, and runny nose.

WARNINGS: Do not excees recommended dosage

Cough Supressant

Nasal Decongestant

Anthihistamine

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

fatherplus'

FATHER JOHNS COUGH MEDICINE PLUS 
nasal decongestant liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0395-9127
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 30 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 30 mL
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE4 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SUCROSE (UNII: C151H8M554)  
GLYCERIN (UNII: PDC6A3C0OX)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0395-9127-941 in 1 CARTON06/17/2019
1118 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/17/2019
Labeler - Humco Holding Group, Inc (825672884)
Registrant - Humco Holding Group, Inc (825672884)
Establishment
NameAddressID/FEIBusiness Operations
Humco Holding Group, Inc825672884label(0395-9127) , pack(0395-9127) , analysis(0395-9127) , manufacture(0395-9127)

Revised: 6/2020
Document Id: a7b08ca6-638b-beb0-e053-2a95a90a9bd3
Set id: a7b05fbb-200e-2433-e053-2995a90a5275
Version: 1
Effective Time: 20200609
 
Humco Holding Group, Inc