Label: GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE tablet
- NDC Code(s): 24689-123-01, 24689-123-02
- Packager: APNAR PHARMA LP
- 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.
Updated August 5, 2022
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- BOXED WARNING (What is this?)
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
Do not use
- 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 using this product.
Ask a doctor before use if you have
- Persistent or chronic cough, such as occurs with smoking, asthma, chronic bronchitis or emphysema
- Cough accompanied by excessive phegm (mucus)
Stop use and ask a doctor if
- Symptons are accompanied by fever, rash or persistent headache
- cough persists for more than 1 week or tends to recur
- A persistent cough may be a sign of a serious condition
If pregnant or breast-feeding, ask a healthcare professional before use.
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE
guaifenesin and dextromethorphan hydrobromide tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:24689-123 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 400 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE K30 (UNII: U725QWY32X) WATER (UNII: 059QF0KO0R) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color white Score 2 pieces Shape CAPSULE Size 18mm Flavor Imprint Code LT13 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:24689-123-01 20 in 1 BOTTLE; Type 0: Not a Combination Product 06/30/2022 2 NDC:24689-123-02 500 in 1 BOTTLE; Type 0: Not a Combination Product 06/30/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 06/30/2022 Labeler - APNAR PHARMA LP (079568229) Establishment Name Address ID/FEI Business Operations INVAHEALTH INC 116840615 label(24689-123) , pack(24689-123) Establishment Name Address ID/FEI Business Operations Apnar Pharma Private Limited 876730408 analysis(24689-123) , manufacture(24689-123)