DOCTOR MANZANILLA COUGH AND COLD syrup

DOCTOR MANZANILLA COUGH AND COLD by

Drug Labeling and Warnings

DOCTOR MANZANILLA COUGH AND COLD by is a Otc medication manufactured, distributed, or labeled by Mid Valley Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENTS (IN EACH 5ML)

Diphenhydramine Hydrochloride 12.5mg

Phenylephrine Hydrochloride 5mL

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 - Do not exceed recommended dosage.

• If nervousness, dizziness, or sleeplessness occurs, discontinue use and consult a doctor.
• 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.

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 marked 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:

Caramel Color, Oregano Extract, Citric Acid, Glycerin, Propylene Glycol, Sorbitol, Sucralose, Edetate Calcuim Disodium, Sodium Benzoate, Natural Chamomile Flavor, Natural Cherry Flavor, Purified Water.

ADVERSE REACTIONS:

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

Doctor Manzanilla CoughCold Carton

Doctor Manzanilla CoughCold Carton Label

Doctor Manzanilla

100%

Manzanilla Natural

Doctor Manzanilla

Syrup Jarabe

Cough & Cold

Tos y Resfriado

Scientifically Formulated

Throat Irritation

Itching Watery eyes

Nasal Congestion

Cough

Bronquial

Irritation

4 FL OZ. (118 ml)

Diphenhydramine HCl 12.5mg/5 mL (Cough Suppressant Antihistamine)

Phenylephrine HCl 5mg/5 mL (Nasal Decongestant)

100% Manzanilla Natural

PARA EL GUSTO DE TU TRANQUIL!IDAD

Alivia!

Tos

Congestion Nasal

Irritacion de Garganta

Estornudo

Picazon de ojos llorosos

Doctor Manzanilla

100% Natural Chamomile

FOR A GREAT SOOTHING TASTE

Relieves!

Cough

Nasal Decongestant

Throat Irritation

Sneezing

Itching watery eyes

Doctor Manzanilla

Distributed by: Midvalley Pharmaceuticals
Raymondville, TX 78580

Doctor Manzanilla CoughCold Container

Doctor Manzanilla CoughCold Container Label

Doctor Manzanilla

Syrup Jarabe

COUGH & COLD

Tos y Resfriado

100%

Manzanilla Natural

PARA E GUSTO DE TU TRANZUILIDAD

100% Natural Chamomile

FOR A GREAT SOOTHING TASTE

Distributed by: Midvalley Pharmaceuticals
Raymondville, TX 78580

Container Label

INGREDIENTS AND APPEARANCE

DOCTOR MANZANILLA COUGH AND COLD 
doctor manzanilla cough and cold syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62558-003
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)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF)
SODIUM BENZOATE (UNII: OJ245FE5EU)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62558-003-16	1 in 1 CARTON	01/09/2017
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	01/09/2017

Labeler - Mid Valley Pharmaceuticals LLC (079227119)

Registrant - Mid Valley Pharmaceuticals LLC (079227119)

Establishment
Name	Address	ID/FEI	Business Operations
PharmaTech LLC		968082094	manufacture(62558-003)