Label: LEADER CHILDRENS MULTI SYMPTOM COLD- dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
- NDC Code(s): 70000-0629-1
- Packager: CARDINAL HEALTH 110, LLC. DBA LEADER
- 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 30, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS (in each 5 mL)
- PURPOSE
-
USES
- helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
- temporarily relieves:
- cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants
- the intensity of coughing
- the impulse to cough to help your child get to sleep
- nasal congestion due to a cold
- stuffy nose
- 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.
- ASK A DOCTOR BEFORE USE IF THE CHILD HAS
- WHEN USING THIS PRODUCT
- STOP USE AND ASK DOCTOR IF
- KEEP OUT OF REACH OF CHILDREN.
-
DIRECTIONS
- do not take more than 6 doses in any 24-hour period
- measure only with dosing cup provided
- do not use dosing cup with other products
- dose as follows or as directed by a doctor
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 - mL=milliliter
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
-
PRINCIPAL DISPLAY PANEL
LEADER
NDC 70000-0629-1
Children's Multi-Symptom Cold
Dextromethorphan HBr
Guaifenesin
Phenylephrine HCl
Cough Suppressant
Expectorant
Nasal Decongestant
Very Berry Flavor
Ages 4+ Years
Relieves:
Stuffy Nose
Chest Congestion
Controls Cough
Breaks Up Mucus
COMPARE TO
CHILDREN'S MUCINEX®
MULTI-SYMPTOM COLD
active ingredients*
4FL OZ (118 mL)
-
INGREDIENTS AND APPEARANCE
LEADER CHILDRENS MULTI SYMPTOM COLD
dextromethorphan hbr, guaifenesin, phenylephrine hcl liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0629 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) D&C RED NO. 33 (UNII: 9DBA0SBB0L) DEXTROSE (UNII: IY9XDZ35W2) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN (UNII: A2I8C7HI9T) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) PROPYL GALLATE (UNII: 8D4SNN7V92) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM ANHYDROUS (UNII: I4807BK602) SODIUM HYDROXIDE (UNII: 55X04QC32I) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color RED Score Shape Size Flavor BERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70000-0629-1 1 in 1 CARTON 03/15/2023 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 03/15/2023 Labeler - CARDINAL HEALTH 110, LLC. DBA LEADER (063997360) Establishment Name Address ID/FEI Business Operations Guardian Drug Company 119210276 MANUFACTURE(70000-0629)