DOCTOR MANZANILLA COUGH SUPPRESSANT AND NASAL DECONGESTANT- diphenhydramine hydrochloride, phenylephrine hydrochloride solution

Doctor Manzanilla Cough Suppressant and Nasal Decongestant by

Drug Labeling and Warnings

Doctor Manzanilla Cough Suppressant and Nasal Decongestant by is a Otc medication manufactured, distributed, or labeled by Mid Valley Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (in each 5mL)

Diphenhydramine Hydrochloride 12.5mg

Phenylephrine Hydrochloride 5mg

Purpose

Antihistamine/Cough Suppressant

Nasal Decongestant

Uses:

Temporarily relieves

• runny nose
• sneezing
• itching of the nose or throat
• itchy, watery eyes due to hay fever or other upper respiratory
• cough associated with a cold
• the cough reflex that causes coughing
• nasal congestion
• Promotes nasal and/or sinus drainage
• temporarily relieves sinus congestion and pressure.

WARNINGS

Warnings:

Do not use

• 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 taking this product.
• With any other product containing diphenhydramine,even one used on skin.
• Do not exceed recommended dosage.
• If nervousness, dizziness, or sleeplessness occurs, discontinue use and consult a doctor.

Ask a doctor before use if you have

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• glaucoma
• a breathing problem such as emphysema or chronic bronchitis
• trouble urinating due an enlarged prostate gland
• cough that occurs that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or if cough is accompanied by excessive phlegm (mucus).

Ask a doctor or pharmacist

before use if you are taking sedatives or tranquilizers

When using this product:

• do not exceed recommended dosage
• may cause excitability especially in children
• may cause "drowsiness"; alcohol, sedatives, and tranquilizers may increase the drowsiness effect
• avoid alcoholic beverages while taking this product
• use caution when driving a motor vehicle or operating machinery.

Stop use and ask a doctor if:

• you get nervous, dizzy, or sleeplessness occurs
• symptoms do not improve within 7 days, tend to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions:

Do not take more than 6 doses in 24 hours.

• Adults and children 12 years of age and over: 2 teaspoonfuls (10mL) every 4 hours
• Children 6 to under 12 years of age: 1 teaspoonfuls (5mL) every 4 hours
• Children under 6 years of age: Consult a doctor

Other information:

Store at controlled room temperature 15º - 30ºC (59º-86ºF). Each dose contains 10 mg sodium.

Inactive ingredients:

Citric Acid, Trisodium Citrate, Glycerin, Propylene Glycol, Sorbitol, Sucralose, Propyl Gllate, Edetate Sodium, Sodium Benzoate, Chamomile Flavor, Oregano Extract, Yellow No. 5

ADVERSE REACTIONS

To report serious side effects associated with the use of this product call the Poison Control Center.

Package Label

Doctor Manzanilla

COUGH SUPPRESSANT & NASAL DECONGESTANT

I RECCOMEND IT

LAURA FLORES
4 FL OZ. (118 ml)

100%
Manzanilla Natural

Relieves!

Cough

Nasal

Decongestant

Throat

Irritation

Sneeze

Bronchial Irritation

Itching watery eyes

Distributed by: Midvalley Pharmaceuticals
Raymondville, TX 78580

7 48252 23732 3

INGREDIENTS AND APPEARANCE

DOCTOR MANZANILLA COUGH SUPPRESSANT AND NASAL DECONGESTANT 
diphenhydramine hydrochloride, phenylephrine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62558-001
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	12.5 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
PROPYL GALLATE (UNII: 8D4SNN7V92)
EDETATE SODIUM (UNII: MP1J8420LU)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62558-001-18	1 in 1 CARTON
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/04/2014

Labeler - Mid Valley Pharmaceuticals LLC (079227119)