Boxed warning
Caution: do not use if imprinted seal under cap is broken or missing
Guaifenesin and Dextromethorphan Hydrobromide Tablets 400 +20 mg
- Manufacturer
- APNAR PHARMA LP | Apnar Pharma Private Limited | APNAR PHARMA LLP
- Effective date
- 2023-01-04
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:41:26
Label at a glance#
ProductGuaifenesin and Dextromethorphan Hydrobromide
Active ingredientGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE
Label structure12 sections
Storage and handling
Other Information store at 15°-30°C (59°-86°F)
Contacts and useful links#
Label contents#
Full prescribing information#
BOXED WARNING SECTION
Caution: do not use if imprinted seal under cap is broken or missing
OTC - ACTIVE INGREDIENT SECTION
Drug Facts
Active Ingredients (per tablet)
Guaifenesin USP...................................... 400 mg
Dextromethorphan Hydrobromide USP...... 20 mg
OTC - PURPOSE SECTION
Purpose
Expectorant
Cough suppressant
INDICATIONS & USAGE SECTION
Uses:
- Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold
- Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus
- Helps make coughs more productive.
WARNINGS SECTION
WARNINGS
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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children
In case of overdose, get medical help or contact poison control center immediately
DOSAGE & ADMINISTRATION SECTION
Directions
- Adults and children 12 years of age and over: take 1 tablet every 4 hours as needed
- Children 6 to 12 years of age: take 1/2 tablet every 4 hours as needed
- Children under 6 years of age: consult a doctor.
Do not exceed 6 doses in 24 hour period or as directed by a doctor
STORAGE AND HANDLING SECTION
Other Information
- store at 15°-30°C (59°-86°F)
INACTIVE INGREDIENT SECTION
Inactive Ingredients
Microcrystalline cellulose, Croscarmellose sodium, Povidone, silicon dioxide, magnesium stearate
OTC - QUESTIONS SECTION
Questions or concerns?
- 1-855-642-2594
SPL UNCLASSIFIED SECTION
Distributed by:
APNAR PHARMA LP
CHINO, CA, 91710
Rev.: 04/2022
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
APNAR PHARMA LP
NDC 24689-123-01
Guaifenesin and Dextromethorphan Hydrobromide Tablets 400 + 20mg- 20s tablets
APNAR PHARMA LP
NDC 24689-123-02
Guaifenesin and Dextromethorphan Hydrobromide Tablets 400 + 20mg- 500s tablets
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 24689-123-01 | 2025-12-13 | C162847 | 48780-1 | 2cef2736-9673-d83d-e063-dadaa90ab31f | Guaifenesin and Dextromethorphan Hydrobromide Tablets 400 +20 mg |
| 24689-123-02 | 2025-12-13 | C162847 | 48780-1 | 2cef2736-9673-d83d-e063-dadaa90ab31f | Guaifenesin and Dextromethorphan Hydrobromide Tablets 400 +20 mg |
| 24689-123-01 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-9673-d83d-e063-dadaa90ab31f | Guaifenesin and Dextromethorphan Hydrobromide Tablets 400 +20 mg |
| 24689-123-02 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-9673-d83d-e063-dadaa90ab31f | Guaifenesin and Dextromethorphan Hydrobromide Tablets 400 +20 mg |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 24689-123-01 | EA - Each | 24689-123 | cff98a93-5761-46a6-859d-4135d7264d94 | 1 | 2023-02-06 |
| 24689-123-02 | EA - Each | 24689-123 | e786bae0-22ff-4529-9ed6-4dc23d8f708e | 1 | 2023-02-06 |
Products#
Every source-derived product name is available through these pages.
- Guaifenesin and Dextromethorphan Hydrobromide
- CELLULOSE, MICROCRYSTALLINE
- POVIDONE K30
- WATER
- GUAIFENESIN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- CROSCARMELLOSE SODIUM
- SILICON DIOXIDE
- MAGNESIUM STEARATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 24689-123 | 24689-123-01, 24689-123-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| WATER | 059QF0KO0R | IACT |
| GUAIFENESIN | 495W7451VQ | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 45d314c2-0246-188b-e063-6394a90a5b9a | e22b0c01-390f-2743-e053-2995a90aee29 | 2025-12-13 | Boxed warning, Warnings | e22b0c01-390f-2743-e053-2995a90aee29 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.