Label: RUNNY NOSE AND COUGH- brompheniramine maleate, dextromethorphan hydrobromide and phenylephrine hydrochloride liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 45014-153-04 - Packager: Accudial Pharmaceutical, Inc.
- 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 November 4, 2009
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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Uses
- temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold, and nasal congestion due to the common cold, hay fever, or other upper respiratory allergies
- temporarily relieves these symptoms due to hay fever (allergic rhinitis):
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
- temporarily restores freer breathing through the nose
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Warnings
Do not use
- to sedate a child or to make a child sleepy
- 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.
Ask a doctor before use if the child has
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- glaucoma
- cough that occurs with too much phlegm (mucus)
- a breathing problem or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema
When using this product
- do not use more than directed
- may cause marked drowsiness
- avoid alcoholic beverages
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
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Directions
- do not take more than 4 doses in any 24-hour period
- to find right dose, use rotating bottle label to dose by weight; otherwise, use chart below to dose by age
- specifically designed for use with enclosed dosing spoon. Use only enclosed dosing spoon to dose this product. Do not use any other dosing device
age dose children 6 to under 12 years 1½-3 tsp. (7.5-15 mL) every 6 hours children under 6 years do not use - Other information
- Inactive ingredients
- Questions?
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PRINCIPAL DISPLAY PANEL - 118 mL Carton
CHILDREN'S
ACCUDIALROTATING DOSING LABEL
ACCURATE DOSING
BY WEIGHTNasal Decongestant
Antihistamine
Cough SuppressantRELIEVES
Nasal Congestion
Runny Nose
Itchy, Watery Eyes
Coughing, SneezingFor Ages 6 to under 12
Alcohol Free
Compares to the
active ingredients in
Children's Dimetapp®
Cold & Cough.GRAPE
FLAVOR4 FL. OZ.
(118 mL)
NDC 45014-153-04Runny Nose & Cough
- SPL UNCLASSIFIED SECTION
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INGREDIENTS AND APPEARANCE
RUNNY NOSE AND COUGH
brompheniramine maleate, dextromethorphan hydrobromide and phenylephrine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:45014-153 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Brompheniramine Maleate (UNII: IXA7C9ZN03) (Brompheniramine - UNII:H57G17P2FN) Brompheniramine Maleate 0.5 mg in 5 mL Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide 5 mg in 5 mL Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride 1.25 mg in 5 mL Inactive Ingredients Ingredient Name Strength Grape (UNII: 6X543N684K) Citric Acid Monohydrate (UNII: 2968PHW8QP) FD&C Blue No. 1 (UNII: H3R47K3TBD) FD&C Red No. 40 (UNII: WZB9127XOA) Glycerin (UNII: PDC6A3C0OX) Propylene Glycol (UNII: 6DC9Q167V3) Water (UNII: 059QF0KO0R) Sodium Benzoate (UNII: OJ245FE5EU) Sodium Citrate (UNII: 1Q73Q2JULR) Saccharin Sodium (UNII: SB8ZUX40TY) Sorbitol (UNII: 506T60A25R) Product Characteristics Color PURPLE Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:45014-153-04 118 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 11/04/2009 Labeler - Accudial Pharmaceutical, Inc. (831999201)