Label: CHILDRENS MULTI SYMPTOM COLD- dextromethorphan hbr, guaifenesin, phenylephrine hcl solution
- NDC Code(s): 59779-634-26
- Packager: CVS Pharmacy
- 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 June 13, 2016
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- Official Label (Printer Friendly)
- Active ingredients (in each 5 mL)
- Purposes
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Uses
- •
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
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- temporarily relieves:
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- cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
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- the intensity of coughing
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- the impulse to cough to help your child get to sleep
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- nasal congestion due to a cold
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- stuffy nose
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Warnings
Do not use
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 your child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
- Keep out of reach of children.
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Directions
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- do not take more than 6 doses in any 24-hour period
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- measure only with dosing cup provided
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- do not use dosing cup with other products
- •
- dose as follows or as directed by a doctor
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- mL = milliliter
Age
Dose
children 6 years to under 12 years
10 mL every 4 hours
children 4 years to under 6 years
5 mL every 4 hours
children under 4 years
do not use
- Inactive ingredients
-
Package/Label Principal Display Panel
Compare to the active ingredients in Children’s Mucinex® Multi-Symptom Cold
Children’s
Multi-Symptom
Cold
DEXTROMETHORPHAN HBr 5 mg
Cough suppressant
GUAIFENESIN 100 mg
Expectorant
PHENYLEPHRINE HCl 2.5 mg
Nasal decongestant
Relieves:
Stuffy nose
Cough
Chest congestion
Beaks up mucus
Alcohol free
Very Berry Flavor Liquid
Ages 4+
Dosage cup included
4 FL OZ (118 mL)
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INGREDIENTS AND APPEARANCE
CHILDRENS MULTI SYMPTOM COLD
dextromethorphan hbr, guaifenesin, phenylephrine hcl solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-634 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 GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 100 mg in 5 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 2.5 mg in 5 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) EDETATE DISODIUM (UNII: 7FLD91C86K) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color RED (clear) Score Shape Size Flavor BERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59779-634-26 1 in 1 CARTON 06/11/2016 1 118 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 06/11/2016 Labeler - CVS Pharmacy (062312574)