Label: DESPEC EDA DROPS- dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid
- NDC Code(s): 11584-1110-1
- Packager: International Ethical Labs
- Category: HUMAN OTC DRUG LABEL
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 October 15, 2018
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- ACTIVE INGREDIENT
INDICATIONS & USAGE
Temporarily relieves these symptoms due to the common cold, hay fever (allergic
rhinitis) or other upper respiratory allergies:
-cough due to minor throat and bronchial irritation
-helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
-nasal congestion reduces swelling of nasal passages
Do not exceed recommended dosage.
Do not use this product
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 DOCTOR
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- OTHER SAFETY INFORMATION
- Product Packaging
INGREDIENTS AND APPEARANCE
DESPEC EDA DROPS
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11584-1110 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 1 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 50 mg in 1 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 2.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM CITRATE (UNII: 1Q73Q2JULR) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11584-1110-1 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/19/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 01/19/2012 Labeler - International Ethical Labs (091176933) Establishment Name Address ID/FEI Business Operations Woodfield Pharmaceuticals, LLC 079398730 manufacture(11584-1110)