DR MANZANILLA PE- phenylephrine hydrochloride, triprolidine hydrochloride syrup

United States - English - NLM (National Library of Medicine)

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Active ingredient:
TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)
Available from:
Key Therapeutics
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Phenylephrine HCl 10 mg       Decongestant Triprolidine HCl 2.5 mg       Antihistamine 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
Authorization status:
OTC monograph final
Authorization number:
70868-703-16

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.

----------

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

Us es

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

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.

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

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

NDC 70868-703-16

Antihistamine Decongestant

Dr. Manzanilla

PE Syrup

Bubble Gum Flavor

16 fl oz (473 mL)

DR MANZANILLA PE

phenylephrine hydrochloride, triprolidine hydrochloride syrup

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:70 8 6 8 -70 3

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

TRIPRO LIDINE HYDRO CHLO RIDE (UNII: YAN7R5L8 9 0 ) (TRIPROLIDINE -

TRIPROLIDINE

2.5 mg

Key Therapeutics

UNII:2L8 T9 S52QM)

HYDROCHLORIDE

in 5 mL

PHENYLEPHRINE HYDRO CHLO RIDE (UNII: 0 4JA59 TNSJ) (PHENYLEPHRINE -

UNII:1WS29 7W6 MV)

PHENYLEPHRINE

HYDROCHLORIDE

10 mg

in 5 mL

Inactive Ingredients

Ingredient Name

Stre ng th

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

WATER (UNII: 0 59 QF0 KO0 R)

HYDRO XYPRO PYL CELLULO SE, UNSPECIFIED (UNII: 9 XZ8 H6 N6 OH)

SO RBITO L (UNII: 50 6 T6 0 A25R)

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

Product Characteristics

Color

S core

S hap e

S iz e

Flavor

BUBBLE GUM

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:70 8 6 8 -70 3-16

473 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 8 /11/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH FINAL

pa rt341

0 8 /11/20 19

Labeler -

Key T herapeutics (080318791)

Revised: 8/2019

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