CURAHIST DM- dextromethorphan hbr, pyrilamine maleate liquid

CuraHIST DM by

Drug Labeling and Warnings

CuraHIST DM by is a Otc medication manufactured, distributed, or labeled by Wittman Pharma, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

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

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 INGREDIENT

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

INDICATIONS & USAGE

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

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.

PURPOSE

Antitussive/Antihistamine

ACTIVE INGREDIENT

Active Ingredients (in each 5 ml teaspoonful)

Dextromethorphan HBr 7.5mg

Pyrilamine Maleate 7.5mg

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CURAHIST DM 
dextromethorphan hbr, pyrilamine maleate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83335-105
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	7.5 mg  in 5 mL
PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL)	PYRILAMINE MALEATE	7.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	APPLE (Apple Pie)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83335-105-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/15/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	01/15/2024

Labeler - Wittman Pharma, Inc. (830980947)

Establishment
Name	Address	ID/FEI	Business Operations
Wittman Pharma, Inc.		830980947	analysis(83335-105) , label(83335-105) , manufacture(83335-105)