OTC - ACTIVE INGREDIENT SECTION
| Active ingredient (in each tablet) Chlorpheniramine maleate 4 mg |
| Active ingredient (in each tablet) Chlorpheniramine maleate 4 mg |
Purpose: Antihistamine |
Uses: temporarily relieves the following symptoms due to hay fever or other upper respiratory allergies: runny nose, sneezing, itching of the nose or throat, itch, watery eyes |
Warnings Ask a doctor before use if you have: glaucoma; a breathing problem such as emphysema or chronic bronchitis; difficulty urinating due to an enlarged prostate gland |
| Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. |
When using this product: excitability may occur, especially in children; drowsiness may occur; avoid alcoholic beverages; alcohol, sedatives and tranquilizers may increase drowsiness; use caution when driving a motor vehicle operating machinery |
| If pregnant or breast-feeding ask a health professional before use. |
Directions Adults and children 12 years and over - 1 tablet every 4 to 6 hours, not to exceed 6 tablets in 24 hours Children 6 to under 12 years of age - 1/2 tablet (break tablet in half) every 4 to 6 hours, not to exceed 3 whole tablets in 24 hours Children under 6 years of age - do not use |
| Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. |
| anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, D-C yellow #10 aluminum lake, magnesium stearate, microcrystalline cellulose, stearic acid. |
| Class | Version | Type | Effective |
|---|---|---|---|
| CHLORPHENIRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d17a97fa-387f-690e-d2be-0083ab044a03 | Product name | 3 | 20170725 |
| 0fdb98e2-b951-a1ce-5715-2b187ba500ef | Product name | 4 | 20170718 |
| c6fba691-a132-4ede-95c6-f8c6bd696636 | Product name | 1 | 20150902 |
| c0200ab5-4954-454e-9676-30b741b245bd | Product name | 1 | 20150730 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49483-242-00 | Allergy Time | 100000 in 1 CARTON | TABLET | 100000 | 2 | |
| 49483-242-01 | Allergy Time | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | 2 | |
| 49483-242-10 | Allergy Time | 1000 in 1 BOTTLE, PLASTIC | TABLET | 1000 | 2 | |
| 49483-242-24 | Allergy Time | 24 in 1 BLISTER PACK | TABLET | 24 | 2 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 49483-242-01 | EA - Each | 49483-242 | a8494711-4c54-4f14-87b2-9680815e4b9b | 1 | 2012-07-24 |
| 49483-242-10 | EA - Each | 49483-242 | e4ae1e68-b550-4f7b-b050-9b1f342b1cb2 | 1 | 2012-07-24 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| chlorpheniramine maleate | ACTIVE INGREDIENT | V1Q0O9OJ9Z | 1 | |
| CHLORPHENIRAMINE | ACTIVE MOIETY | 3U6IO1965U | 1 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 49483-242 | 49483-242-00, 49483-242-01, 49483-242-10, 49483-242-24 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ANHYDROUS LACTOSE | 3SY5LH9PMK | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| D&C YELLOW NO. 10 | 35SW5USQ3G | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| CHLORPHENIRAMINE MALEATE | V1Q0O9OJ9Z | 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 |
|---|---|---|---|---|---|---|
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / ORAL | 980 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / ORAL | 750 mg | ||
| ANHYDROUS LACTOSE | ANHYDROUS LACTOSE | 3SY5LH9PMK | TABLET / ORAL | 6795 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / ORAL | 750 mg | ||
| ANHYDROUS LACTOSE | ANHYDROUS LACTOSE | 3SY5LH9PMK | TABLET / ORAL | 6795 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / ORAL | 750 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | TABLET / ORAL | 80 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET / ORAL | 736 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET / ORAL | 736 mg | ||
| ANHYDROUS LACTOSE | ANHYDROUS LACTOSE | 3SY5LH9PMK | TABLET / ORAL | 6795 mg | ||
| ANHYDROUS LACTOSE | ANHYDROUS LACTOSE | 3SY5LH9PMK | TABLET / ORAL | 6795 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / ORAL | 6184 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / ORAL | 980 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / ORAL | 336 mg | ||
| ANHYDROUS LACTOSE | ANHYDROUS LACTOSE | 3SY5LH9PMK | TABLET / ORAL | 6795 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / ORAL | 750 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / ORAL | 6184 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / ORAL | 336 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / ORAL | 336 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / ORAL | 750 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / ORAL | 336 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / ORAL | 980 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET / ORAL | 736 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | TABLET / ORAL | 80 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | TABLET / ORAL | 80 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET / ORAL | 736 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET / ORAL | 736 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / ORAL | 6184 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / ORAL | 336 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / ORAL | 980 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | TABLET / ORAL | 80 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / ORAL | 6184 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / ORAL | 980 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | TABLET / ORAL | 80 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / ORAL | 6184 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 |
|---|---|---|---|---|---|---|
| Allergy Time | CHLORPHENIRAMINE MALEATE | Time Cap Labs Inc | 588c424a-8dd6-417e-8f76-2ce0cc2b0c12 | 2018-12-17 | Warnings | 49483-242-01 49483-242-24 49483-242-00 49483-242-10 49483-242 49483024201 49483024210 49483024224 49483024200 7d393588-61e4-0606-e053-2a91aa0a83b2 588c424a-8dd6-417e-8f76-2ce0cc2b0c12 |
Adverse event summaries are temporarily unavailable. Other product information remains available.