Active Ingredients And Purpose
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each tablet) Chlorpheniramine maleate 4 mg
OTC - PURPOSE SECTION
Purpose: Antihistamine
242R CHLOR MAL
- Set ID
- 588c424a-8dd6-417e-8f76-2ce0cc2b0c12
- Manufacturer
- Time Cap Labs Inc
- Effective date
- 2018-12-17
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 22:57:43
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.
Products
- Allergy Time
- CHLORPHENIRAMINE
NDC Codes
Ingredients
| 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 |
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.
Source Document
Official SPL XML cached by FDA.report ยท DailyMed PDF
- XML object
- dailymed/588c424a-8dd6-417e-8f76-2ce0cc2b0c12/7d393588-61e4-0606-e053-2a91aa0a83b2.xml
- XML SHA-256
- 3d55d254632abc1987379ec9ecac3292034931b4a2baa7d984e2094941941e72
- XML bytes
- 25685
Legacy File Index
| Folder | File | Date |
|---|---|---|
| otc | 242R.jpg | 2018-12-18 |
| otc | 7d393588-61e4-0606-e053-2a91aa0a83b2.xml | 2018-12-18 |