OTC - ACTIVE INGREDIENT SECTION
Active Ingredients
Acetaminophen 325 mg.Guaifenesin 200 mg Phenylephrine HCl 5 mgActive Ingredients
Acetaminophen 325 mg.Guaifenesin 200 mg Phenylephrine HCl 5 mgPain Reliever, Fever Reducer, Expectorant, Nasal Decongestant, Cough Suppressant
Directions: adults and children 12 years of age and over • take 2 tablets with water every 6-8 hours, as needed • do not take more than 8 tablets in 24 hours children under 12 years of age • do not give to children under 12 years of age
Uses: or the temporary relief of the following cold symptoms: • minor aches and pains • headache • sore throat • nasal congestion • cough • helps loose phlegm (mucus) and thin bronchial secretions to make coughs more productive • temporarily reduces fever
If pregnant or breast-feeding baby, ask a health professional
before use.
KEEP OUT OF REACH OF CHILDREN.
Inactive ingredients:
Maltodextrin, Microcrystalline Cellulose, Povidone, Sodium Starch Glycolate, Starch, Stearic Acid
MM1
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1294471 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / guaiFENesin 200 MG / pseudoephedrine HCl 30 MG Oral Tablet | PSN | 1 |
| 1294471 | acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / guaifenesin 200 MG / pseudoephedrine hydrochloride 30 MG Oral Tablet | SCD | 1 |
| 1294471 | APAP 325 MG / Dextromethorphan Hydrobromide 15 MG / Guaifenesin 200 MG / Pseudoephedrine Hydrochloride 30 MG Oral Tablet | SY | 1 |
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 52904-456-02 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-93af-f424-e053-dadaa90a57ce | Drug Facts |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 52904-456-02 | Cold Relief Severe Pain Cough | 2 in 1 PACKET | TABLET | 2 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 52904-456 | COLD RELIEF SEVERE PAIN COUGH (ACETAMINOPHEN,GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HYDROBROMIDE) TABLET [SELECT CORPORATION] | 1 | Legacy NDC, 1 package rows | 20121106_f38a784b-cfc3-4238-9cd3-56c1dba94e6f.zip |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | 1 | |
| DEXTROMETHORPHAN HYDROBROMIDE | ACTIVE INGREDIENT | 9D2RTI9KYH | 1 | |
| GUAIFENESIN | ACTIVE INGREDIENT | 495W7451VQ | 1 | |
| PHENYLEPHRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 04JA59TNSJ | 1 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | 1 | |
| DEXTROMETHORPHAN | ACTIVE MOIETY | 7355X3ROTS | 1 | |
| GUAIFENESIN | ACTIVE MOIETY | 495W7451VQ | 1 | |
| PHENYLEPHRINE | ACTIVE MOIETY | 1WS297W6MV | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 1 | |
| MALTODEXTRIN | INACTIVE INGREDIENT | 7CVR7L4A2D | 1 | |
| POVIDONE K29/32 | INACTIVE INGREDIENT | 390RMW2PEQ | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 52904-456 | 52904-456-02 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| MALTODEXTRIN | 7CVR7L4A2D | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | 5856J3G2A2 | IACT |
| POVIDONE K29/32 | 390RMW2PEQ | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
| GUAIFENESIN | 495W7451VQ | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TROCHE / ORAL | 300 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CAPSULE, EXTENDED RELEASE / ORAL | 194 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / ORAL | 6184 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, DELAYED RELEASE / ORAL | 80 mg | ||
| MALTODEXTRIN | MALTODEXTRIN | 7CVR7L4A2D | TABLET, CHEWABLE / ORAL | 292 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | EMULSION / ORAL | NA | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / BUCCAL | 16.6 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | EMULSION / TOPICAL | NA | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / SUBLINGUAL | 409 mg | ||
| MALTODEXTRIN | MALTODEXTRIN | 7CVR7L4A2D | FILM, SOLUBLE / ORAL | 19 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | SUSPENSION/ DROPS / ORAL | 90 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, CHEWABLE / ORAL | 180 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / BUCCAL | 18 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 21 mg | ||
| MALTODEXTRIN | MALTODEXTRIN | 7CVR7L4A2D | TABLET, EXTENDED RELEASE / ORAL | 3239 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, DELAYED RELEASE / ORAL | 713 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, COATED / ORAL | 256 mg | ||
| MALTODEXTRIN | MALTODEXTRIN | 7CVR7L4A2D | PASTE / ORAL | 1050 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | POWDER, FOR SUSPENSION / ORAL | 34 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | GRANULE, FOR SUSPENSION / ORAL | 278 mg | ||
| MALTODEXTRIN | MALTODEXTRIN | 7CVR7L4A2D | TABLET, EFFERVESCENT / ORAL | 14404 mg | ||
| MALTODEXTRIN | MALTODEXTRIN | 7CVR7L4A2D | SOLUTION / ORAL | 1451 mg | ||
| MALTODEXTRIN | MALTODEXTRIN | 7CVR7L4A2D | SUSPENSION / ORAL | 6040 mg | ||
| MALTODEXTRIN | MALTODEXTRIN | 7CVR7L4A2D | TABLET / ORAL | 320 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | SHAMPOO / TOPICAL | 9.7 %w/w | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | GRANULE, DELAYED RELEASE / ORAL | 789.6 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 144 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / SUBLINGUAL | 43.2 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | PASTILLE / ORAL | NA | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED / ORAL | 176 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE, DELAYED RELEASE / ORAL | 366 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | AEROSOL, FOAM / TOPICAL | 8 %w/w | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | SUSPENSION, EXTENDED RELEASE / ORAL | 113 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | PELLET / ORAL | 1140 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | GRANULE / ORAL | 29520 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CAPSULE, DELAYED RELEASE / ORAL | 216 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, ORALLY DISINTEGRATING / ORAL | 1800 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, COATED / ORAL | 42.4 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IMPLANT / INTRAVITREAL | 1.66 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / ORAL | 1116 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CONCENTRATE / ORAL | NA | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | OINTMENT / TOPICAL | 15 %w/w | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | IMPLANT / SUBCUTANEOUS | 1.04 mg | ||
| MALTODEXTRIN | MALTODEXTRIN | 7CVR7L4A2D | LOZENGE / ORAL | 175 mg | ||
| MALTODEXTRIN | MALTODEXTRIN | 7CVR7L4A2D | TABLET, COATED / ORAL | 5.6 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / BUCCAL | 6 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, EXTENDED RELEASE / ORAL | 184 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, COATED / ORAL | 920 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / ORAL | 336 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, DELAYED RELEASE / ORAL | 2210 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | SOLUTION / TOPICAL | NA | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | SUSPENSION, EXTENDED RELEASE / ORAL | 1120 mg | ||
| MALTODEXTRIN | MALTODEXTRIN | 7CVR7L4A2D | CAPSULE / ORAL | 200 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | DROPS / ORAL | NA | ||
| MALTODEXTRIN | MALTODEXTRIN | 7CVR7L4A2D | GRANULE, FOR SUSPENSION / ORAL | 952 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED / ORAL | 992 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | POWDER, FOR SOLUTION / ORAL | 690 mg | ||
| MALTODEXTRIN | MALTODEXTRIN | 7CVR7L4A2D | TABLET, ORALLY DISINTEGRATING / ORAL | 12 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | POWDER, FOR SUSPENSION / ORAL | 1203 mg/5ml | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / SUBLINGUAL | 9 mg |
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 |
|---|---|---|---|---|---|---|
| 54839955-9752-4d0c-8de8-051c3e1f40ef | f38a784b-cfc3-4238-9cd3-56c1dba94e6f | 2012-10-15 | Warnings | 54839955-9752-4d0c-8de8-051c3e1f40ef f38a784b-cfc3-4238-9cd3-56c1dba94e6f |
Adverse event summaries are temporarily unavailable. Other product information remains available.