Label: DOCTOR MANZANILLA COUGH SUPPRESSANT AND NASAL DECONGESTANT- diphenhydramine hydrochloride, phenylephrine hydrochloride solution
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Contains inactivated NDC Code(s)
NDC Code(s): 62558-001-18 - Packager: Mid Valley Pharmaceuticals LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated June 29, 2015
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- SPL UNCLASSIFIED SECTION
- Active ingredients (in each 5mL)
- Purpose
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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.
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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).
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.
- Directions:
- Other information:
- Inactive ingredients:
- ADVERSE REACTIONS
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Package Label
Doctor Manzanilla
COUGH SUPPRESSANT & NASAL DECONGESTANT
I RECCOMEND IT
LAURA FLORES
4 FL OZ. (118 ml)100%
Manzanilla NaturalRelieves!
Cough
Nasal
Decongestant
Throat
Irritation
Sneeze
Bronchial Irritation
Itching watery eyes
Distributed by: Midvalley Pharmaceuticals
Raymondville, TX 785807 48252 23732 3
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INGREDIENTS AND APPEARANCE
DOCTOR MANZANILLA COUGH SUPPRESSANT AND NASAL DECONGESTANT
diphenhydramine hydrochloride, phenylephrine hydrochloride solutionProduct 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)