Dr Manzanilla PE Syrup

Manufacturer
Key Therapeutics
Effective date
2019-08-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:08:28

Label at a glance#

ProductDr Manzanilla PE
Active ingredientTRIPROLIDINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

temporarily relieves these symptoms due to common cold, 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

In case of overdose, get medical help or contact a Poison Control Center right away. D o n ot exceed recommended dosage. 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 ...

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 PE

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 PE Syrup

Drug Facts

Purpose

OTC - PURPOSE SECTION

Phenylephrine HCl 10 mg       Decongestant

Triprolidine HCl 2.5 mg       Antihistamine

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms due to common cold, 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.

Do not use this product

OTC - DO NOT USE SECTION

  • If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

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, chronic bronchitis, or emphysema 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
  • 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 serious condition.
  • If new symptoms reoccur

Directions:

DOSAGE & ADMINISTRATION SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

Keep out of the 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.

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.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

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 70868-703-16
Antihistamine • Decongestant
Dr. Manzanilla
PE Syrup

Bubble Gum Flavor
16
fl oz (473 mL)

PRINCIPAL DISPLAY PANEL NDC 70868-703-16 Antihistamine • Decongestant Dr. Manzanilla PE Syrup Bubble Gum Flavor 16 fl oz (473 mL)PRINCIPAL DISPLAY PANEL NDC 70868-703-16 Antihistamine • Decongestant Dr. Manzanilla PE Syrup Bubble Gum Flavor 16 fl oz (473 mL)

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70868-703-16ML - Milliliter70868-703f9221663-af4c-4a1d-bb63-41246830b75012019-09-05

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70868-70370868-703-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 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
1b72609e-465f-49ac-a459-c0f85274738fa053a509-fa93-4929-bcba-5ccae9ffdda22020-04-07WarningsExact identifier
spl set id: a053a509-fa93-4929-bcba-5ccae9ffdda2

Reported adverse events (FAERS/openFDA)#

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