OTC Medication Information: M-Hist PD

M-HIST PD- triprolidine hydrochloride liquid
Method Pharmaceuticals, LLC

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.

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)

PRINCIPAL DISPLAY PANEL
58657-535-30
M- Hist PD
Liquid
1 mL
1 oz. (30 mL)
(click image for full-size original)
M-HIST PD triprolidine hydrochloride liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58657-535
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRIPROLIDINE HYDROCHLORIDE (TRIPROLIDINE) TRIPROLIDINE HYDROCHLORIDE 0.625 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
FD&C RED NO. 40
GLYCERIN
PROPYLENE GLYCOL
WATER
SODIUM BENZOATE
TRISODIUM CITRATE DIHYDRATE
SORBITOL
SUCRALOSE
Product Characteristics
Color red Score
Shape Size
Flavor BANANA, STRAWBERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58657-535-30 1 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER
1 30 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (58657-535-30)
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)

Revised: 02/2020 Method Pharmaceuticals, LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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