Label: LEADER CHILDRENS MUCUS RELIEF- dextromethorphan hbr, guaifenesin, phenylephrine hcl solution
- NDC Code(s): 70000-0261-1
- Packager: Cardinal Health 110, LLC. dba Leader
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 11, 2024
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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
- •
- 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
Children’s Mucus Relief
Multi-Symptom Cold
Dextromethorphan HBr Cough Suppressant
Guaifenesin Expectorant
Phenylephrine HCl Nasal Decongestant
Berry Flavor
Ages 4-12 Years
COMPARE TO CHILDREN’S MUCINEX® MULTI-SYMPTOM COLD active ingredients
Relief of:
Stuffy Nose
Cough
Chest Congestion
Breaks Up Mucus
4 FL OZ (118 mL)
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INGREDIENTS AND APPEARANCE
LEADER CHILDRENS MUCUS RELIEF
dextromethorphan hbr, guaifenesin, phenylephrine hcl solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0261 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:70000-0261-1 1 in 1 CARTON 03/22/2017 01/31/2025 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 Drug M012 03/22/2017 01/31/2025 Labeler - Cardinal Health 110, LLC. dba Leader (063997360)
