Label: CHILDRENS GILTUSS HONEY COUGH AND CHEST CONGESTION- dextromethorphan hbr, guaifenesin solution
- NDC Code(s): 58552-141-04
- Packager: Gil Pharmaceutical Corp
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 24, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
-
INDICATIONS & USAGE
Uses
- temporarily relieves:
- cough due to minor throat and bronchial irritation associated with the common cold or inhaled irritants
- the intensity of coughing
- the impulse to cough to help your child get to sleep
- helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive and drain bronchial tubes
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WARNINGS
Warnings
Do not useif your child is now 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 taking this product.
Ask a doctor before use if the child has
- cough that occurs with too much phlegm (mucus)
- a persistent or chronic cough as occurs with asthma
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DOSAGE & ADMINISTRATION
Directions
- do not take more than 6 doses in any 24-hour period
- use enclosed dosinc cup
- keep dosage cup for use with this product
- ml = milliliters
children under 4 years Consult a doctor children 4 to under 6 years 2.5 mL every 4 hours children 6 to under 12 years 5 mL every 4 hours children 12 years and over 10 mL every 4 hours
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CHILDRENS GILTUSS HONEY COUGH AND CHEST CONGESTION
dextromethorphan hbr, guaifenesin solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58552-141 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 DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 5 mL Inactive Ingredients Ingredient Name Strength CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SUCRALOSE (UNII: 96K6UQ3ZD4) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) HONEY (UNII: Y9H1V576FH) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) Product Characteristics Color yellow (Light yellow) Score Shape Size Flavor HONEY, LEMON Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58552-141-04 1 in 1 CARTON 06/22/2020 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 06/22/2020 Labeler - Gil Pharmaceutical Corp (176826592) Establishment Name Address ID/FEI Business Operations Dextrum Laboratories Inc 007392322 manufacture(58552-141)
