Label: DESPEC- dextromethorphan hydrobromide, guaifenesin, phenyllephrine hydrochloride liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 11584-1047-6 - Packager: INTERNATIONAL ETHICAL LABS
- 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 October 17, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
-
Indications & Usage
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
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Warnings
Warnings
Do not exceed recommended dosage.
Do not use this product
if you are 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
prescription drug contains an MAOI, ask a
doctor or pharmacist before taking this
product.
If pregnant or breast-feeding, ask a health
professional before use.
-
Ask a doctor
Ask a doctor before use if you have
a cough that lasts or is chronic such
as occurs with smoking, asthma, chronic
bronchitis, or emphysema.
a cough that occurs with too much
phlegm (mucus)
heart disease
high blood pressure
thyroid disease
diabetes
trouble urinating due to an enlarged
prostate gland
- Stop use
- Keep out of reach of children
-
Dosage & Administration
Do not exceed recommended dosage.
Use with enclosed dosage cup.
Adults and Children
12 years of age and
over:
Children 6 to under
12 years of age:
Children under 6
years of age:
2 teaspoonfuls (2 TSP)
every 4 hours, not to
exceed 6 doses in
24 hours.
1 teaspoonful (1 TSP)
every 4 hours, not to
exceed 6 doses in
24 hours.
Consult a doctor.
- Other safety information
- Inactive ingredient
- Questions? Comments?
- Package Label Principal Display Panel
-
INGREDIENTS AND APPEARANCE
DESPEC
dextromethorphan hydrobromide, guaifenesin, phenyllephrine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11584-1047 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 PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg in 5 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 100 mg in 5 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) MALTITOL (UNII: D65DG142WK) DIPROPYLENE GLYCOL (UNII: E107L85C40) Product Characteristics Color Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11584-1047-6 1 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/11/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 01/11/2016 Labeler - INTERNATIONAL ETHICAL LABS (091176933) Establishment Name Address ID/FEI Business Operations WOODFIELD PHARMACEUTICAL, LLC 079398730 manufacture(11584-1047)
