Label: NITE TIME COLD AND COUGH- diphenhydramine hydrochloride and phenylephrine hydrochloride solution
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Contains inactivated NDC Code(s)
NDC Code(s): 45014-159-04 - 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
- Uses
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Warnings
Do not use in a child under 6 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
- with any other product containing diphenhydramine, even one used on skin
- for the purpose of making your child sleepy.
Ask a doctor before use if the child has heart disease
- high blood pressure thyroid disease
- diabetes
- glaucoma cough that occurs with too much phlegm (mucus)
- chronic cough that lasts, or as occurs with asthma
- a breathing problem such as chronic bronchitis.
When using this product
- do not exceed recommended dosage marked drowsiness may occur
- sedatives and tranquilizers may increase drowsiness excitability may occur, especially in children.
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) TSP = teaspoon under 6 yrs. ask a doctor 6 to under 12 2 TSP or as directed by a doctor - Other information
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- Inactive ingredients
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PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label
ACCUDIAL®
Children's
Nite Time
Cold and CoughDiphenhydramine
(Antihistamine/Cough Suppressant)Phenylephrine HCl (Nasal Decongestant)
Relieves Cough • Runny Nose
Stuffy Nose • Itchy ThroatEarth-Friendly
Package!For Ages 6 yrs to under 12 yrs
Tamper Evident
Compares to Children's Triaminic®
Night Time Cold & CoughGRAPE
FLAVORNDC 45014-159-04
4 FL. OZ. (118 mL)
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INGREDIENTS AND APPEARANCE
NITE TIME COLD AND COUGH
diphenhydramine hydrochloride and phenylephrine hydrochloride solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:45014-159 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M) Diphenhydramine Hydrochloride 6.25 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 Blue No. 1 (UNII: H3R47K3TBD) 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 PURPLE Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:45014-159-04 118 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(45014-159) , MANUFACTURE(45014-159) , RELABEL(45014-159) , REPACK(45014-159)