Label: DAYTIME COUGH AND COLD- dextromethorphan hydrobromide and phenylephrine hydrochloride solution
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Contains inactivated NDC Code(s)
NDC Code(s): 45014-158-04 - 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 February 6, 2013
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- ACTIVE INGREDIENT
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Warnings
Do not use in a child under 4 years of age
- in a child who is 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 the child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
Ask a doctor before use if the child has heart disease
- high blood pressure
- thyroid disease
- diabetes
- cough that occurs with too much phlegm (mucus)
- chronic cough that lasts, or as occurs with asthma.
Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occurs.
- symptoms do not improve within 7 days or occur with a fever.
- cough persists for more than 7 days, comes back, or occurs with a fever, rash, or persistent headache. These could be signs of a serious condition.
Consult your pharmacist or health care provider for any appropriate, additional dosage delivery device necessary for use when a physician recommends a dose that is different than the doses that appear on the dosage delivery device that accompanies this product.
Age (yr) Dose (TSP) under 4 yrs. ask a doctor 4 to under 6 1 TSP 6 to under 12 2 TSP or as directed by a doctor TSP = teaspoon - Other information
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PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label
ACCUDIAL®
Children's
Daytime
Cough and ColdDextromethorphan HBr (Cough Suppressant)
Phenylephrine HCl (Nasal Decongestant)
Relieves Cough • Stuffy Nose
Earth-Friendly
Package!For Ages 4 yrs to under 12 yrs
Tamper Evident
Compares to Children's Triaminic ®
Day Time Cold & CoughCHERRY
FLAVORNDC 45014-158-04
4 FL. OZ. (118 mL)
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INGREDIENTS AND APPEARANCE
DAYTIME COUGH AND COLD
dextromethorphan hydrobromide and phenylephrine hydrochloride solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:45014-158 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide 5 mg in 5 mL Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride 2.5 mg in 5 mL Inactive Ingredients Ingredient Name Strength Benzoic Acid (UNII: 8SKN0B0MIM) Citric Acid Monohydrate (UNII: 2968PHW8QP) Edetate Disodium (UNII: 7FLD91C86K) FD&C Red No. 40 (UNII: WZB9127XOA) Propylene Glycol (UNII: 6DC9Q167V3) Water (UNII: 059QF0KO0R) Sodium Citrate (UNII: 1Q73Q2JULR) Saccharin Sodium (UNII: SB8ZUX40TY) Sorbitol (UNII: 506T60A25R) Product Characteristics Color RED Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:45014-158-04 118 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 02/01/2013 Labeler - Accudial Pharmaceutical, Inc. (831999201) Establishment Name Address ID/FEI Business Operations Bio-Pharm, Inc. 801652546 ANALYSIS(45014-158) , MANUFACTURE(45014-158) , RELABEL(45014-158) , REPACK(45014-158)