Label: CHILDREN COUGH AND COLD- chlorpheniramine maleate, dextromethorphan hbr, pseudoephedrine hcl liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 0536-1243-97 - Packager: RUGBY LABORATORIES
- 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 March 15, 2021
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings
Do not use in a child who is takin 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 child's prescription drug contains on MAOI, ask a doctor or pharmacist before giving this product.
Ask a doctor before use if child has
- diabetes
- glaucoma
- thyroid disease
- heart diseae
- high blood pressure
- cough that occurs with too much phlegm (mucus)
- a breathing problem such as chronic bronchitis
- chronic cough that lasts such as occurs with asthma or tranquilizers
When using this product
- do not use more than directed
- excitability may occur, especially in children
- drowsiness may occur
- sedatives and tranquilizers may increase drowsiness
Stop use and ask a doctor if
- the child gets nervous, dizzy or sleepless
- cough lasts more than 7 days, comes back or occurs with fever, rash or persistent headache. A persistent cough may be sign of a serious condition.
- Symptoms do not get better within 7 days or occur with fever
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CHILDREN COUGH AND COLD
chlorpheniramine maleate, dextromethorphan hbr, pseudoephedrine hcl liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-1243 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 2 mg in 10 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 10 mL PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg in 10 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C RED NO. 40 (UNII: WZB9127XOA) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SODIUM CITRATE (UNII: 1Q73Q2JULR) SUCRALOSE (UNII: 96K6UQ3ZD4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0536-1243-97 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 08/01/2019 Labeler - RUGBY LABORATORIES (079246066)
