Label: LITTLE COLDS DECONGESTANT PLUS COUGH- dextromethorphan hydrobromide and phenylephrine hydrochloride liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 63029-402-01 - Packager: Medtech Products 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 October 22, 2010
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- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Active Ingredients
- Purpose
- Uses
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Warnings
Do not use:
- with any other products containing decongestants or cough suppressants. Ask a doctor or pharmacist before using with other drugs if you are not sure.
- Do not give this product to a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional condition, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you are uncertain whether your child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
Drug Interaction Precaution:
Ask a doctor before use if the child has:
- heart or thyroid disease
- high blood pressure or diabetes
- a cough accompanied by excessive phlegm (mucus) or has a persistent or chronic cough such as occurs with asthma
Stop use and ask a doctor if:
- your child becomes nervous, dizzy or sleepless
- symptoms do not get better within 7 days, or are accompanied by fever
- cough persists for more than 7 days, tends to recur, or is accompanied by high fever, rash, or persistent headaches. These could be signs of a serious condition.
- with any other products containing decongestants or cough suppressants. Ask a doctor or pharmacist before using with other drugs if you are not sure.
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Directions
- Give this medicine by mouth only.
- Only use the enclosed dropper. Do not use any other dropper, spoon or dosing device when giving this medicine to your child.
- Fill the enclosed dropper to the prescribed level and slowly dispense the liquid into your child’s mouth (towards the inner cheek).
- Do not give more than 6 doses in any 24-hour period (see overdose warning).
- If needed, repeat dose every 4 hours or as directed by a doctor.
Age (yr) Dose Under 4 Do not use 4 to under 6 1 mL 6 to under 12 2 mL - Give this medicine by mouth only.
- Other Information
- Inactive Ingredients:
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LITTLE COLDS DECONGESTANT PLUS COUGH
dextromethorphan hydrobromide and phenylephrine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63029-402 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 1.0 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 2.5 mg in 1.0 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color WHITE Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63029-402-01 1 in 1 BOX 1 30 mL in 1 BOTTLE, DROPPER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 09/01/2010 Labeler - Medtech Products Inc. (122715688) Establishment Name Address ID/FEI Business Operations Denison Pharmaceuticals, Inc. 001207208 MANUFACTURE
