FDA.reportPublic FDA data

Dr Manzanilla Infant

Manufacturer
Key Therapeutics
Effective date
2019-08-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:15:19

Label at a glance#

ProductDr Manzanilla Infant
Active ingredientTRIPROLIDINE HYDROCHLORIDE
Label structure9 sections

Indications and 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

Dosage and administration

AGE DOSE Children 4 to under 6 years of age: 1 dropperful (1.0 mL) every 4 to 6 hours not to exceed 4 doses (4.0 mL) in 24 hours. Children 2 to under 4 years of age: 2/3 dropperful (0.67 mL) every 4 to 6 hours, not to exceed 4 doses (2.67 mL) in 24 hours. Infants 4 months to under 2 years age: 1/3 dropperful (0.33 mL) every 4 to 6 hours, not to exceed 4 doses (1.33 mL) in 24 hours.

Storage and handling

Store at 15°-30 ° C (59 °-86 ° F). Supplied in a tight, light-resistant container with a child-resistant cap.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Dr. Manzanilla Infant

Key Therapeutics, 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.

Dr. Manzanilla Pediatric Syrup

Drug Facts

Purpose

OTC - PURPOSE SECTION

Triprolidine HCl……….0.938 mg…………Antihistamine

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Sodium Benzoate, Purified Water, Sucralose, Hydroxypropyl Cellulose, Sorbitol, Bubblegum

Flavor.

Uses

INDICATIONS & USAGE SECTION

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

Warnings:

WARNINGS SECTION

Do not exceed recommended dosage.

Ask a doctor before use if the child has

OTC - ASK DOCTOR SECTION

  • a breathing problem such as emphysema or chronic bronchitis

Ask a doctor before use if the child is taking sedatives or tranquilizers.

When using this product

OTC - WHEN USING SECTION

  • excitability may occur, especially in children may cause drowsiness
  • alcohol, sedatives and tranquilizers may increase the drowsiness effect

Stop use and ask a doctor if new symptoms occur.

OTC - STOP USE SECTION

KEEP THIS PRODUCT 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.

Do not exceed recommended dosage.

Directions:

DOSAGE & ADMINISTRATION SECTION

AGEDOSE
Children 4 to under 6 years of age:1 dropperful (1.0 mL) every 4 to 6 hours not to exceed 4 doses (4.0 mL) in 24 hours.
Children 2 to under 4 years of age:2/3 dropperful (0.67 mL) every 4 to 6 hours, not to exceed 4 doses (2.67 mL) in 24 hours.
Infants 4 months to under 2 years age:1/3 dropperful (0.33 mL) every 4 to 6 hours, not to exceed 4 doses (1.33 mL) in 24 hours.

Other Information

STORAGE AND HANDLING SECTION

Store at 15°-30 ° C (59 °-86 ° F).

Supplied in a tight, light-resistant container with a child-resistant cap.

Questions? Comments?

OTC - QUESTIONS SECTION

Call 1-888-981-8337

Manufactured for:

Key Therapeutics, LLC

Flowood, MS 39232

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70868-701-30
Dr. Manzanilla
Infant
Antihistamine
Bubble Gum Flavor
1 fl oz (30 mL)

PRINCIPAL DISPLAY PANEL NDC 70868-701-30 Dr. Manzanilla Infant Antihistamine Bubble Gum Flavor 1 fl oz (30 mL)PRINCIPAL DISPLAY PANEL NDC 70868-701-30 Dr. Manzanilla Infant Antihistamine Bubble Gum Flavor 1 fl oz (30 mL)

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70868-701-30ML - Milliliter70868-701e0ccfa5f-7e3f-460c-9c0c-d5d7c8f89b4412019-09-05

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70868-70170868-701-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
TRIPROLIDINE HYDROCHLORIDEYAN7R5L890ACTIB
SODIUM BENZOATEOJ245FE5EUIACT
WATER059QF0KO0RIACT
SUCRALOSE96K6UQ3ZD4IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED9XZ8H6N6OHIACT
SORBITOL506T60A25RIACT

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
983d5ba4-d9aa-43a8-a9f5-64a2f2ae05ff3fb0eac7-73dd-400f-b463-ce7abdcf3c3d2020-04-07WarningsExact identifier
spl set id: 3fb0eac7-73dd-400f-b463-ce7abdcf3c3d

Reported adverse events (FAERS/openFDA)#

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