FDA.reportPublic FDA data

M-Hist PD

Manufacturer
Method Pharmaceuticals, LLC
Effective date
2021-12-30
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:19:57

Label at a glance#

ProductM-Hist PD
Active ingredientTRIPROLIDINE HYDROCHLORIDE
Label structure9 sections

Indications and 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

Dosage and administration

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                ...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

58657-535-30
M-Hist PD
Liquid

Drug Facts

Active ingredient (in each mL)

OTC - ACTIVE INGREDIENT SECTION

Triprolidine HCl 0.625 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

  • May cause excitability, especially in children

Do Not Use

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

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

When using this product

OTC - WHEN USING SECTION

  • 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:

OTC - STOP USE SECTION

  • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.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)PRINCIPAL DISPLAY PANEL 58657-535-30 M- Hist PD Liquid 1 mL 1 oz. (30 mL)

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58657-535-302020-02-11C16284748780-19d75b9d1-1140-f424-e053-dadaa90a57ceM-Hist PD Liquid
58657-535-302020-01-31C16284748780-19d75b9d1-1140-f424-e053-dadaa90a57ceM-Hist PD Liquid

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58657-535-30ML - Milliliter58657-535132e6922-44df-48c4-b92f-caab421f23ca12016-12-07

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58657-53558657-535-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
TRIPROLIDINE HYDROCHLORIDEYAN7R5L890ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d45ef5a6-32d7-32a5-e053-2995a90af51a9e03e4b8-eea0-4afb-ab63-ff36c858b8142021-12-30WarningsExact identifier
spl id: d45ef5a6-32d7-32a5-e053-2995a90af51a
spl set id: 9e03e4b8-eea0-4afb-ab63-ff36c858b814

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.