Label: ALLERGY AND STUFFY NOSE- chlorpheniramine maleate and phenylephrine hydrochloride liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 45014-141-04 - 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 11, 2009
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
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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.
- 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
- a breathing problem such as asthma or 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
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Directions
- may be given every 4 hours. Do not give more than 6 doses in 24 hours unless directed by a doctor.
- 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 under 4 years of age do not use children 4 to under 6 years of age do not use unless directed by a doctor children 6 to under 12 years of age 1-2 tsp. (5-10 mL) - Other information
- Inactive ingredients
- Questions?
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PRINCIPAL DISPLAY PANEL - 118 mL Carton
CHILDREN'S
ACCUDIALROTATING DOSING LABEL
Allergy
& Stuffy NoseACCURATE DOSING
BY WEIGHTChlorpheniramine maleate
(Antihistamine)Phenylephrine HCl
(Nasal Decongestant)Itchy, Watery Eyes
Runny Nose
Stuffy Nose
SneezingFor Ages 6 to under 12
Compares to
Children's Triaminic®
Cold & Allergy.ORANGE
FLAVOR4 FL. OZ.
(118 mL)
NDC 45014-141-04 -
INGREDIENTS AND APPEARANCE
ALLERGY AND STUFFY NOSE
chlorpheniramine maleate and phenylephrine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:45014-141 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Chlorpheniramine Maleate (UNII: V1Q0O9OJ9Z) (Chlorpheniramine - UNII:3U6IO1965U) Chlorpheniramine Maleate 1 mg in 5 mL Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride 2.5 mg in 5 mL Inactive Ingredients Ingredient Name Strength Orange (UNII: 5EVU04N5QU) Benzoic Acid (UNII: 8SKN0B0MIM) Citric Acid Monohydrate (UNII: 2968PHW8QP) Edetate Disodium (UNII: 7FLD91C86K) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) Propylene Glycol (UNII: 6DC9Q167V3) Water (UNII: 059QF0KO0R) Sodium Citrate (UNII: 1Q73Q2JULR) Saccharin Sodium (UNII: SB8ZUX40TY) Sorbitol (UNII: 506T60A25R) Product Characteristics Color ORANGE Score Shape Size Flavor ORANGE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:45014-141-04 118 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 11/11/2009 Labeler - Accudial Pharmaceutical, Inc. (831999201)