Indications and uses
temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies: runny nose sneezing itching of the nose or throat itchy, watery eyes
PediaVent ™ Chewable Tablets
- Manufacturer
- CarWin Pharmaceutical Associates, LLC
- Effective date
- 2014-08-12
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:35:31
Label at a glance#
ProductPediaVent
Active ingredientDEXBROMPHENIRAMINE MALEATE
Label structure10 sections
Dosage and administration
Do not exceed recommended dosage. AGE DOSE Adults and Children 12 years of age and older: 2 tablets every 4 to 6 hours, not to exceed 12 tablets in 24 hours, or as directed by a doctor. Children 6 to under 12 years of age 1 tablet every 4 to 6 hours, not to exceed 6 tablets in 24 hours, or as directed by a doctor. Children under 6 years of age Consult a doctor
Storage and handling
Store at 15°-30° C (59°-86° F). Tamper evident by foil seal under cap. Do not use if foil seal is missing or broken. Dispense in a tight, light-resistant container with a child-resistant cap.
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredients (in each tablet)
Dexbrompheniramine Maleate 1 mg
Purpose
Antihistamine
Uses
temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:
- runny nose
- sneezing
- itching of the nose or throat
- itchy, watery eyes
Warnings
Do not exceed recommended dosage.
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- trouble urinating due to an enlarged prostate gland
Ask a doctor before use if you are taking sedatives or tranquilizers
OTC - WHEN USING SECTION
When using this product
- excitability may occur, especially in children
- may cause drowsiness
- alcohol, sedatives and tranquilizers may increase the drowsiness effect
- avoid alcoholic beverages
- use caution when driving a motor vehicle or operating machinery
OTC - STOP USE SECTION
Stop use and ask a doctor if
- new symptoms occur
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of the reach of children.
SPL UNCLASSIFIED SECTION
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
Do not exceed recommended dosage.
| AGE | DOSE |
|---|---|
| Adults and Children 12 years of age and older: | 2 tablets every 4 to 6 hours, not to exceed 12 tablets in 24 hours, or as directed by a doctor. |
| Children 6 to under 12 years of age | 1 tablet every 4 to 6 hours, not to exceed 6 tablets in 24 hours, or as directed by a doctor. |
| Children under 6 years of age | Consult a doctor |
Other Information
Store at 15°-30° C (59°-86° F).
Tamper evident by foil seal under cap. Do not use if foil seal is missing or broken.
Dispense in a tight, light-resistant container with a child-resistant cap.
Inactive ingredients
berry flavor, magnesium stearate, mannitol, microcrystalline cellulose, silicon dioxide, stearic acid, sucralose, and xylitol.
Questions? Comments?
Call 1-866-633-9033.
PRINCIPAL DISPLAY PANEL - 60 Tablet Bottle Label
NDC 15370-112-60
Antihistamine
PediaVent™
CHEWABLE TABLETS
Each chewable tablet contains:
Dexbrompheniramine Maleate 1 mg
Berry Flavored
CARWIN
PHARMACEUTICAL
ASSOCIATES, LLC
60 Tablets
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 15370-112-60 | 2023-06-08 | C162847 | 48780-1 | 9d75b9d0-7441-f424-e053-dadaa90a57ce | PediaVent ™ Chewable Tablets |
| 15370-112-60 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-7441-f424-e053-dadaa90a57ce | PediaVent ™ Chewable Tablets |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 15370-112-60 | EA - Each | 15370-112 | 6d5700b4-8ba2-4a08-9099-d8110650c282 | 1 | 2014-09-03 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| DEXBROMPHENIRAMINE MALEATE | ACTIVE INGREDIENT | BPA9UT29BS | 1 | |
| DEXBROMPHENIRAMINE | ACTIVE MOIETY | 75T64B71RP | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 1 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 1 | |
| SUCRALOSE | INACTIVE INGREDIENT | 96K6UQ3ZD4 | 1 | |
| XYLITOL | INACTIVE INGREDIENT | VCQ006KQ1E | 1 |
Products#
Every source-derived product name is available through these pages.
- PediaVent
- DEXBROMPHENIRAMINE MALEATE
- DEXBROMPHENIRAMINE
- MAGNESIUM STEARATE
- MANNITOL
- CELLULOSE, MICROCRYSTALLINE
- SILICON DIOXIDE
- STEARIC ACID
- SUCRALOSE
- XYLITOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 15370-112 | 15370-112-60 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DEXBROMPHENIRAMINE MALEATE | BPA9UT29BS | ACTIB |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MANNITOL | 3OWL53L36A | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| XYLITOL | VCQ006KQ1E | IACT |
Source Document#
Inactive ingredient matches#
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 / SUBLINGUAL | 17.5 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | INJECTION, SUSPENSION / INTRAVENOUS | 2.5 %w/v | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / SUBLINGUAL | 9 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | SOLUTION / INTRAVENOUS | 15400 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 1576 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | CAPSULE, DELAYED RELEASE / ORAL | 2043 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | GRANULE / ORAL | 5.4 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE / RESPIRATORY (INHALATION) | NA | ||
| MANNITOL | MANNITOL | 3OWL53L36A | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS | 658 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | SUSPENSION, EXTENDED RELEASE / ORAL | 16 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | IMPLANT / SUBCUTANEOUS | 0.5 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED PELLETS / ORAL | 69 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, EXTENDED RELEASE / ORAL | 5119 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FOR SUSPENSION / ORAL | 220 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TROCHE / ORAL | 60 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET, CHEWABLE / ORAL | 28 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | INJECTION, SOLUTION / INTRAVENOUS | 15400 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 615 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | TABLET, FOR SUSPENSION / ORAL | 7621 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | INJECTION, SOLUTION / SUBMUCOSAL | 2.94 %w/v | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CAPSULE / ORAL | 90 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SOLUTION / ORAL | 1.8 mg/120ml | ||
| MANNITOL | MANNITOL | 3OWL53L36A | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 300 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / BUCCAL | 18 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER / TOPICAL | 104 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | GUM, CHEWING / BUCCAL | 70 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | SUSPENSION / ORAL | 1600 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | CONCENTRATE / INTRAVENOUS | 220 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | INSERT / VAGINAL | 8 mg | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | PASTE / ORAL | 180 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | PELLET / ORAL | 24 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, EXTENDED RELEASE / ORAL | 173 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SUSPENSION / ORAL | 400 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / VAGINAL | 8 %w/w | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, CHEWABLE / ORAL | 180 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | SYSTEM / INTRAVITREAL | 0.02 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | INJECTION, SUSPENSION / INTRAMUSCULAR | 71 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CREAM / TOPICAL | NA | ||
| MANNITOL | MANNITOL | 3OWL53L36A | SOLUTION, GEL FORMING / DROPS / OPHTHALMIC | 4 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER, FOR SOLUTION / ORAL | 280 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | INSERT / VAGINAL | 69 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | PELLET / SUBCUTANEOUS | 0.97 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 9 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE / ORAL | 5000 mg | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | TABLET, ORALLY DISINTEGRATING / ORAL | 360 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 616 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, SUGAR COATED / ORAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, DELAYED RELEASE PARTICLES / ORAL | 170 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET / SUBLINGUAL | 12 mg | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | TABLET / ORAL | 15.04 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | SOLUTION / SUBCUTANEOUS | 4.54 %w/v | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | GRANULE, FOR SUSPENSION / ORAL | 14 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | PELLET / ORAL | 34 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | POWDER, FOR SUSPENSION / ORAL | 7093 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 69 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | GRANULE / ORAL | 29520 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | TABLET / BUCCAL | 360 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | TROCHE / ORAL | 14594 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | SOLUTION / ORAL | 869 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CAPSULE, EXTENDED RELEASE / ORAL | 64 mg |
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 |
|---|---|---|---|---|---|---|
| 24be6011-9b83-451a-89a9-5d9318656266 | f0b90cc2-901c-4498-b892-d8883182b6fd | 2023-06-07 | Warnings | f0b90cc2-901c-4498-b892-d8883182b6fd |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.