Dr Manzanilla Pediatric by Key Therapeutics Dr Manzanilla PE Syrup

Dr Manzanilla Pediatric by

Drug Labeling and Warnings

Dr Manzanilla Pediatric by is a Otc medication manufactured, distributed, or labeled by Key Therapeutics. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DR MANZANILLA PE- phenylephrine hydrochloride, triprolidine hydrochloride syrup 
Key Therapeutics

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.

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Dr Manzanilla PE Syrup

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

Active ingredients (in each 5 mL teaspoonful):

Purpose

Phenylephrine HCl 10 mg       Decongestant

Triprolidine HCl 2.5 mg       Antihistamine

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

Warnings:

Do not exceed recommended dosage.

Do not use this product

  • 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

  • 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

  • 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

  • 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:

If pregnant or breast-feeding, 

ask a health professional before use.

Keep out of the reach of children.

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

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

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

Questions? Comments?

Call 1-888-981-8337

Manufactured for:

Key Therapeutics, LLC

Flowood, MS 39232

PRINCIPAL DISPLAY PANEL

70868-703-16

Antihistamine Decongestant
Doctor
Manzanilla PE Syrup

Each teaspoonful   (5mL) contains:

Phenylephrine HCl 10 mg
Triprolidine HCl       2.5 mg

Sugar-Free Dye Free
Alcohol Free
Bubblegum Flavor
16 fl oz (473 mL)

70868-703-16
Antihistamine  Decongestant
Doctor Manzanilla PE Syrup
Each teaspoonful   (5mL) contains:

Phenylephrine HCl   10 mg Triprolidine HCl       2.5 mg
Sugar-Free  Dye Free 
Alcohol Free 
Bubblegum Flavor 
16 fl oz (473 mL)

DR MANZANILLA PE 
phenylephrine hydrochloride, triprolidine hydrochloride syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70868-703
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM) TRIPROLIDINE HYDROCHLORIDE2.5 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM BENZOATE (UNII: OJ245FE5EU)  
WATER (UNII: 059QF0KO0R)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
Color    Score    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70868-703-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product08/11/201903/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34108/11/201903/31/2020
Labeler - Key Therapeutics (080318791)

Revised: 4/2020
 
Key Therapeutics