M-HIST PD- triprolidine hydrochloride liquid

M-Hist PD by

Drug Labeling and Warnings

M-Hist PD by is a Otc medication manufactured, distributed, or labeled by Method Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

58657-535-30
M-Hist PD
Liquid

Drug Facts

Active ingredient (in each mL)

Triprolidine HCl 0.625 mg

Purpose

Antihistamine

Uses

• temporarily relieves: ■runny nose
  
• sneezing ■itching of nose and throat
  
• itchy, watery eyes due to hay fever or other upper respiratory allergies or allergic rhinitis

Warnings

• May cause excitability, especially in children

Do Not Use

• if you or your children are taking sedatives or tranquilizers, without first consulting your doctor
  
• with any other product containing triprolidine

Ask a doctor before use if your child has

• glaucoma
  
• a breathing problem such as emphysema or chronic bronchitis
  
• difficulty in urination due to enlargement of the prostate gland

When using this product

• do not use more than directed
  
• may cause drowsiness
  
• avoid alcoholic drinks
  
• alcohol, sedatives, and tranquilizers may increase drowsiness
  
• be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if:

• nervousness, dizziness or sleeplessness occurs
  
• symptoms do not improve within 7 days or are accompanied by a fever

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

Keep out of reach of children.

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

Directions

• take every 6 hours
  
• do not take more than 4 doses in 24 hours or as directed by a doctor
  
• do not give more than directed or exceed the recommended daily dosage
  
• use only with enclosed dropper
  
• do not use enclosed dropper for any other drug product

Adults and children 12 years of age and over       4 mL (2.5 mg)
Children 6 to under 12 years of age             2 mL (1.25 mg)
Children under 6 years of age                   ask a doctor

• store at controlled room temperature 15°-30°C (59°-86°F)
  
• Tamper Evident: Do not use if seal is broken or missing.

Inactive ingredients

Banana flavor, citric acid anhydrous, FD&C Red #40, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol, strawberry flavor, sucralose.

Questions?

Call 1-877-250-3427

Distributed by:
Method Pharmaceuticals, LLC
Fort Worth, TX 76118

Professional Labeling

Take under guidance of Health Professionals.

Children 4 months to under 2 years of age      0.5 mL (0.313 mg)
Children 2 to under 4 years of age      1 mL (0.626 mg)
Children 4 to under 6 years of age      1.5 mL (0.938 mg)

Take every 6 hours.

Do not exceed 4 doses in 24 hours.

PRINCIPAL DISPLAY PANEL

58657-535-30
M- Hist PD
Liquid
1 mL
1 oz. (30 mL)

INGREDIENTS AND APPEARANCE

M-HIST PD 
triprolidine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58657-535
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM)	TRIPROLIDINE HYDROCHLORIDE	0.625 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	red	Score
Shape		Size
Flavor	BANANA, STRAWBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58657-535-30	1 in 1 CARTON	11/08/2016
1		30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	11/08/2016

Labeler - Method Pharmaceuticals, LLC (060216698)