DOCTOR MANZANILLA ALLERGY AND DECONGESTANT RELIEF syrup

Doctor Manzanilla Allergy and Decongestant Relief by

Drug Labeling and Warnings

Doctor Manzanilla Allergy and Decongestant Relief by is a Otc medication manufactured, distributed, or labeled by Mid Valley Pharmaceuticals LLC, Pharmatech 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

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 allergies or allergic rhinitis
• 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. If symptoms do not improve within seven days or are accompanied by fever, 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 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:

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

Doctor Manzanilla Allergy Carton Label

Doctor Manzanilla Allergy Carton Label

Doctor Manzanilla

ALLERGY

100%

Natural Chamomile

Doctor Manzanilla

ALLERGY &

DECONGESTANT RELIEF

ALIVIO DE ALERGIA &

DESCONGESTIONANTE

4 FL OZ. (118 ml)

Diphenhydramine HCl

(Antihistamine)

Phenylephrine HCl

(Nasal Decongestant)

100% Manzanilla Natural

PARA EL GUSTO DE TU TRANQUIL!IDAD

Alivia!

Alergias

Congestion Nasal

Irritacion de Garganta

Estornudo

Ojos llorosos

por fiebre de heno

Antistaminico

Doctor Manzanilla

100% Natural Chamomile

FOR A GREAT SOOTHING TASTE

Relieves!

Allergy

Nasal Decongestant

Itchy Throat

Sneezing

Itching watery eyes

Antihistamine

Doctor Manzanilla

Distributed by: Midvalley Pharmaceuticals
Raymondville, TX 78580

Bar Code

7 62558 00204 1

Doctor Manzanilla Allergy Container Label

Doctor Manzanilla Allergy Container Label

100% Natural Chamomile

Doctor Manzanilla

ALLERGY &

DECONGESTANT RELIEF

ALIVIO DE ALERGIA & DESCONGESTIONANTE

4 FL OZ. (118 mL)

Distributed by: Midvalley Pharmaceuticals
Raymondville, TX 78580

Bar Code

7 62558 00204 1

Container Label

INGREDIENTS AND APPEARANCE

DOCTOR MANZANILLA ALLERGY AND DECONGESTANT RELIEF 
doctor manzanilla allergy and decongestant relief syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62558-002
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	5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF)
GLYCERIN (UNII: PDC6A3C0OX)
OREGANO (UNII: 0E5AT8T16U)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
Water (UNII: 059QF0KO0R)
Sodium Benzoate (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62558-002-04	1 in 1 CARTON	01/12/2017
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	01/12/2017

Labeler - Mid Valley Pharmaceuticals LLC (079227119)

Registrant - Mid Valley Pharmaceuticals LLC (079227119)

Establishment
Name	Address	ID/FEI	Business Operations
Pharmatech LLC		968082094	manufacture(62558-002)