Label: DOCTOR MANZANILLA COUGH AND COLD syrup
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Contains inactivated NDC Code(s)
NDC Code(s): 62558-003-16 - 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 April 30, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- PURPOSE:
-
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.
- DIRECTIONS:
- OTHER INFORMATION:
- INACTIVE INGREDIENTS:
- ADVERSE REACTIONS:
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Doctor Manzanilla CoughCold Carton
Doctor Manzanilla CoughCold Carton Carton
Doctor Manzanilla
100% Natural chamomile
Doctor Manzanilla Syrup
Cough & Cold
Scientifically Formulated
Throat Irritation
Itching Watery eyes
Nasal Congestion
Cough
Irritation
4 FL OZ. (118 mL)
Diphenhydramine HCl 12.5mg/5 mL (Cough Suppressant Antihistamine)
Phenylephrine HCl 5mg/5 mL (Nasal Decongestant)
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, LLC
Raymondville, TX 78580 -
INGREDIENTS AND APPEARANCE
DOCTOR MANZANILLA COUGH AND COLD
doctor manzanilla cough and cold syrupProduct 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 STEVIA LEAF (UNII: 6TC6NN0876) SODIUM CITRATE (UNII: 1Q73Q2JULR) SORBITOL SOLUTION (UNII: 8KW3E207O2) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SUCRALOSE (UNII: 96K6UQ3ZD4) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM BENZOATE (UNII: OJ245FE5EU) WATER (UNII: 059QF0KO0R) CHAMOMILE (UNII: FGL3685T2X) Product Characteristics Color brown (Caramel Color) Score Shape Size Flavor CHERRY (Natural) Imprint Code Contains 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)