FDA Label for Doctor Manzanilla Cough And Cold
View Indications, Usage & Precautions
Doctor Manzanilla Cough And Cold Product Label
The following document was submitted to the FDA by the labeler of this product Mid Valley Pharmaceuticals Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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.
- 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).
- 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.
Ask a doctor before use If you have:
Ask a doctor or pharmacist
before use if you are taking sedatives or tranquilizers.
When using this product:
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 15° - 30°C (59°-86°F). 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
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