Label: CHILDRENS MUCINEX STUFFY NOSE AND COLD- guaifenesin and phenylephrine hydrochloride solution
- 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.
Updated September 2, 2016
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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.
Ask a doctor before use if the child has
- heart disease
- high blood pressure
- thyroid disease
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with asthma
Stop use and ask a doctor if
- your child gets nervous, dizzy or sleepless
- symptoms do not get better within 7 days or occur with fever
- cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton
INGREDIENTS AND APPEARANCE
CHILDRENS MUCINEX STUFFY NOSE AND COLD
guaifenesin and phenylephrine hydrochloride solution
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63824-284 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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) propyl gallate (UNII: 8D4SNN7V92) water (UNII: 059QF0KO0R) sodium benzoate (UNII: OJ245FE5EU) sorbitol (UNII: 506T60A25R) sucralose (UNII: 96K6UQ3ZD4) trisodium citrate dihydrate (UNII: B22547B95K) xanthan gum (UNII: TTV12P4NEE) Product Characteristics Color PINK Score Shape Size Flavor BERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63824-284-64 1 in 1 CARTON 07/13/2012 1 118 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 07/13/2012 Labeler - Reckitt Benckiser LLC (094405024)