Active Ingredients And Purpose
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each tablet) Chlorpheniramine maleate 4 mg
OTC - PURPOSE SECTION
Purpose: Antihistamine>
4a1aa746-7568-426e-838f-d3bd663e9204
- Set ID
- 4a1aa746-7568-426e-838f-d3bd663e9204
- Manufacturer
- State of Florida DOH Central Pharmacy
- Effective date
- 2013-09-09
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:38:55
Key Label Information
Uses
INDICATIONS & USAGE SECTION
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
WARNINGS SECTION
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
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding ask a health professional before use.
Directions And Dosage
DOSAGE & ADMINISTRATION SECTION
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
Other Label Information
INACTIVE INGREDIENT SECTION
anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, D-C yellow #10 aluminum lake, magnesium stearate, microcrystalline cellulose, stearic acid.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
This Product was Repackaged By: State of Florida DOH Central Pharmacy 104-2 Hamilton Park Drive Tallahassee, FL 32304 United States
Products
- Allergy Time
- CHLORPHENIRAMINE
NDC Codes
Ingredients
| Name | UNII | Kind |
|---|---|---|
| CHLORPHENIRAMINE MALEATE | V1Q0O9OJ9Z | ACTIB |
| 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 |
Complete SPL Sections
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each tablet) Chlorpheniramine maleate 4 mg
OTC - PURPOSE SECTION
Purpose: Antihistamine>
INDICATIONS & USAGE SECTION
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 SECTION
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
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.
OTC - WHEN USING SECTION
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
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding ask a health professional before use.
DOSAGE & ADMINISTRATION SECTION
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
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
INACTIVE INGREDIENT SECTION
anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, D-C yellow #10 aluminum lake, magnesium stearate, microcrystalline cellulose, stearic acid.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
This Product was Repackaged By: State of Florida DOH Central Pharmacy 104-2 Hamilton Park Drive Tallahassee, FL 32304 United States
Source Document
Official SPL XML cached by FDA.report ยท DailyMed PDF
- XML object
- dailymed/4a1aa746-7568-426e-838f-d3bd663e9204/d47df14d-46f6-4b35-ae73-4a9b59825c31.xml
- XML SHA-256
- 6f77d687cc67ca1d596f87c3eb36f098007a179aacbaa7b6f93b91766802dc7b
- XML bytes
- 18327
Legacy File Index
| Folder | File | Date |
|---|---|---|
| otc | Chlorphineramine 4mg.jpg | 2014-04-04 |
| otc | d47df14d-46f6-4b35-ae73-4a9b59825c31.xml | 2014-04-04 |