Dr Manzanilla Pediatric

Manufacturer
Key Therapeutics
Effective date
2019-08-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:15:22

Label at a glance#

ProductDr Manzanilla Pediatric
Active ingredientTRIPROLIDINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies: cough due to minor throat or bronchial irritation runny nose sneezing itching of the nose or throat itchy, watery eyes nasal congestion (reduces swelling of nasal passages)

Dosage and administration

AGE DOSE Adults and Children 12 years of age and older: 1 teaspoonful (5 mL) every 4 hours, not to exceed 4 teaspoonfuls (20 mL) in 24 hours or as directed by a doctor. Children 6 to under 12 years of age: ½ teaspoonful (2.5 mL) every 4 hours, not to exceed 2 teaspoonfuls (10 mL) in 24 hours or as directed by a doctor. Children under 6 years of age: Consult a doctor

Storage and handling

Store at 15°-30 ° C (59 °-86 ° F). Tamper evident by foil seal under cap. Do not use if foil seal is missing or broken. Dispense in a tight, light-resistant container with a child-resistant cap.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Dr. Manzanilla Pediatric Syrup

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 HCI……….2.5 mg…………Antihistamine

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

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

Flavor.

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:

  • cough due to minor throat or bronchial irritation
  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes
  • nasal congestion (reduces swelling of nasal passages)

Warnings:

WARNINGS SECTION

Do not exceed recommended dosage.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • a breathing problem such as emphysema or chronic bronchitis
  • heart disease, high blood pressure, thyroid disease, diabetes, glaucoma
  • a persistent or chronic cough such occurs with smoking, asthma
  • a cough that occurs with too much phlegm (mucus)
  • trouble urinating due to an enlarged prostate gland.

Ask a doctor before use if you are 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 avoid alcoholic beverages
  • use caution when driving a motor vehicle or operating machinery

Stop use and ask a doctor if:

OTC - STOP USE SECTION

  • nervousness, dizziness or sleeplessness occur 
  • cough or nasal congestion persists for more than 1 week, tends to recur or is accompanied by a fever, rash or persistent headache. These could be signs of a more serious condition.
  • if new symptoms occur

These can be signs of a serious condition.

If pregnant or breastfeeding, ask a health professional before use.

OTC - PREGNANCY OR BREAST FEEDING 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
Adults and Children 12 years of age and older:1 teaspoonful (5 mL) every 4 hours, not to exceed 4 teaspoonfuls (20 mL) in 24 hours or as directed by a doctor.
Children 6 to under 12 years of age:½ teaspoonful (2.5 mL) every 4 hours, not to exceed 2 teaspoonfuls (10 mL) in 24 hours or as directed by a doctor.
Children under 6 years of age:Consult a doctor

Other Information

STORAGE AND HANDLING SECTION

Store at 15°-30 ° C (59 °-86 ° F).

Tamper evident by foil seal under cap. Do not use if foil seal is missing or broken. Dispense 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 70868-702-08
Antihistamine
 
Dr. Manzanilla

Pediatric
Bubble Gum Flavor

8 fl oz (237 mL)

PRINCIPAL DISPLAY PANEL NDC 70868-702-08 Antihistamine Dr. Manzanilla Pediatric Bubble Gum Flavor 8 fl oz (237 mL)PRINCIPAL DISPLAY PANEL NDC 70868-702-08 Antihistamine Dr. Manzanilla Pediatric Bubble Gum Flavor 8 fl oz (237 mL)

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70868-702-08ML - Milliliter70868-702d16a2185-7696-4f39-9247-c0125a5e993b12019-09-05

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70868-70270868-702-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

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
8cff6946-2b0e-4f86-815d-c73cd77b45d5f147ebbb-fb5c-4edb-9c67-6b358b9389e02020-04-07WarningsExact identifier
spl set id: f147ebbb-fb5c-4edb-9c67-6b358b9389e0

Reported adverse events (FAERS/openFDA)#

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