Label: DESPEC DM- dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride syrup
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Contains inactivated NDC Code(s)
NDC Code(s): 11584-1046-4 - Packager: International Ethical Laboratories, Inc
- 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 November 2, 2021
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- Official Label (Printer Friendly)
- Drug Facts
- Purpose
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Uses
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
- Warnings
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Do not use this product
- If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emtional conditions, or Parkinson's disease). or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
- Ask a doctor before use if you have
- Stop use and ask a doctor if
- If pregnant or breast-feeding
- Keep out of reach of children
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Directions
Do not exceed recommeneded dosage.
- Use with enclosed dosage cup.
Adults and children 12 years of age and over------2 teaspoonfuls ( 2 TSP) every 4 hours, not to exceed 6 doses in 24 hours.
Children 6 to under 12 years of age........1 teaspoonful (1 TSP) every 4 hours, not to exceed 6 doses in 24 hours.
Children under 6 years of age....... Consult a doctor
- Other information
- Inactive ingredients
- Questions? Comments?
- Principal Display Panel-Label
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INGREDIENTS AND APPEARANCE
DESPEC DM
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride syrupProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11584-1046 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 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 5 mg in 5 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) MALTITOL (UNII: D65DG142WK) GLYCERIN (UNII: PDC6A3C0OX) SODIUM CITRATE (UNII: 1Q73Q2JULR) SORBITOL (UNII: 506T60A25R) Product Characteristics Color Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11584-1046-4 120 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/19/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 02/19/2014 Labeler - International Ethical Laboratories, Inc (091176933) Establishment Name Address ID/FEI Business Operations Woodfield Pharmaceutical, LLC 079398730 manufacture(11584-1046)
Principal Display Panel-120 mL Bottle Label