CURAHIST DM- dextromethorphan hbr, pyrilamine maleate liquid 
Wittman Pharma, Inc.

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CuraHIST DM

Directions: Do not exceed the recommended dosage.

Adults and children 12 years of age and over - 4 teaspoonfuls every 6-8 hours, not

To exceed 16 teaspoonfuls in 24 hours, or as directed by a doctor

Children 6 years to under12 years of age - 2 teaspoonfuls every 6-8 hours, not

to exceed 8 teaspoonfuls in 24 hours, or as directed by a doctor

Children under 6 years of age - consult a doctor

Warnings

Do not exceed recommended dosage.

■ a persistent cough may be a sign of a serious condition.

If cough persist for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache, consult a doctor.

Do not use this product

■ if you are now taking a prescription monoamine oxidase inhibitor (MADI)(certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MADI drug. If you do not know if your prescription drug contains an MADI, ask a doctor or pharmacist before taking 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

Ask a doctor before use if you have

■ a breathing problem such as emphysema or chronic bronchitis ■glaucoma ■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 ■ sedatives and tranquilizers may increase drowsiness effect ■avoid alcoholic beverages ■ use caution when driving a motor vehicle or operating machinery

If pregnant or breast-feeding, ask a health professional before use.

Inactive ingredients: Citric acid, flavor, methylparaben, monoammonium glycyrrhizinate, potassium citrate, potassium sorbate, propylene glycol, propylparaben, purified water, sorbitol, sucralose

Uses temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:

■ runny nose ■sneezing ■itching of the nose or throat

■ itchy, watery eyes ■cough due to minor throat and bronchial irritation associated with a cold ■alleviates cough to help you sleep ■nonnarcotic cough suppressant for the relief of cough

Keep out of reach of children.

In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

Antitussive/Antihistamine

Active Ingredients (in each 5 ml teaspoonful)

Dextromethorphan HBr 7.5mg

Pyrilamine Maleate 7.5mg

CuraHIST DM Label

CURAHIST DM 
dextromethorphan hbr, pyrilamine maleate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83335-105
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE7.5 mg  in 5 mL
PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE7.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
SORBITOL (UNII: 506T60A25R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
POTASSIUM CITRATE (UNII: EE90ONI6FF)  
Product Characteristics
Color    Score    
ShapeSize
FlavorAPPLE (Apple Pie) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83335-105-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/15/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01201/15/2024
Labeler - Wittman Pharma, Inc. (830980947)
Establishment
NameAddressID/FEIBusiness Operations
Wittman Pharma, Inc.830980947analysis(83335-105) , label(83335-105) , manufacture(83335-105)

Revised: 4/2024
Document Id: 1547dc8e-6664-14b1-e063-6394a90a37db
Set id: 1019d607-dbd1-5fa0-e063-6394a90aa4d4
Version: 3
Effective Time: 20240404
 
Wittman Pharma, Inc.