Indications and uses
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat
use only with enclosed dosing cup adults and children 6 years and over 2 teaspoonfuls (tsp) daily; do not take more than 2 teaspoonfuls (tsp) in 24 hours children 2 to under 6 years of age 1 teaspoonful (tsp) daily; do not take more than 1 teaspoonful (tsp) in 24 hours children under 2 years of age ask a doctor consumers with liver or kidney disease ask a doctor
do not use if carton is opened, or if imprinted safety seal is broken or missing see bottom panel for expiration date store between 20° to 25°C (68° to 77°F)
Drug Facts
Loratadine 5 mg
Antihistamine
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
Do not use if you have ever had an allergic reaction to this product or any of its ingredients.
Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
When using this product do not take more than directed. Taking more than directed may cause drowsiness.
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
| adults and children 6 years and over | 2 teaspoonfuls (tsp) daily; do not take more than 2 teaspoonfuls (tsp) in 24 hours |
| children 2 to under 6 years of age | 1 teaspoonful (tsp) daily; do not take more than 1 teaspoonful (tsp) in 24 hours |
| children under 2 years of age | ask a doctor |
| consumers with liver or kidney disease | ask a doctor |
glycerin, grape flavor, maltitol solution, masking agent, noncrystallizing sorbitol solution, phosphoric acid, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sodium phosphate monobasic dihydrate, sucralose powder.
Call 1-866-923-4914
Distributed By
Geiss, Destin & Dunn, Inc.
Peachtree City, GA 30269
NDC 50804-092-08
GOODSENSE®
Ages two years & older
Children's
Loratadine
Syrup
(Loratadine Oral Solution)
5 mg/5 mL Antihistamine
24 Hour Non-Drowsy†
Allergy Relief Sugar Free
Indoor & Outdoor Allergy
Relief of:
Sneezing,
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose
Grape
flavored syrup
Dye free
Compare to active ingredient in
Children's Claritin®*
100%
SATISFACTION
GUARANTEED
4 FL OZ (120 mL)
† When taken as directed. See Drug Facts Panel.

| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
| 6084a4f4-5437-c9a5-caec-5361ee075a59 | Product name | 1 | 20140508 |
| 90c5639a-61b0-88d6-ddcf-21888e94869a | Product name | 1 | 20140508 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50804-092-08 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-9e1d-f424-e053-dadaa90a57ce | Good Sense ® Children's Loratadine |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50804-092-08 | Good Sense Childrens Loratadine | 1 in 1 CARTON | SOLUTION | 1 | 2 | |
| 50804-092-08 | Good Sense Childrens Loratadine | 120 mL in 1 BOTTLE | SOLUTION | 120 | 2 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Loratadine | ACTIVE INGREDIENT | 7AJO3BO7QN | 2 | |
| Loratadine | ACTIVE MOIETY | 7AJO3BO7QN | 2 | |
| glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | 2 | |
| phosphoric acid | INACTIVE INGREDIENT | E4GA8884NN | 2 | |
| polyethylene glycols | INACTIVE INGREDIENT | 3WJQ0SDW1A | 2 | |
| propylene glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | 2 | |
| sodium benzoate | INACTIVE INGREDIENT | OJ245FE5EU | 2 | |
| sodium metabisulfite | INACTIVE INGREDIENT | 4VON5FNS3C | 2 | |
| sodium phosphate, monobasic, dihydrate | INACTIVE INGREDIENT | 5QWK665956 | 2 | |
| sorbitol | INACTIVE INGREDIENT | 506T60A25R | 2 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 50804-092 | 50804-092-08 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Loratadine | 7AJO3BO7QN | ACTIB |
| glycerin | PDC6A3C0OX | IACT |
| sorbitol | 506T60A25R | IACT |
| phosphoric acid | E4GA8884NN | IACT |
| polyethylene glycols | 3WJQ0SDW1A | IACT |
| propylene glycol | 6DC9Q167V3 | IACT |
| water | 059QF0KO0R | IACT |
| sodium benzoate | OJ245FE5EU | IACT |
| sodium metabisulfite | 4VON5FNS3C | IACT |
| sodium phosphate, monobasic, dihydrate | 5QWK665956 | IACT |
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 |
|---|---|---|---|---|---|---|
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SYRUP / ORAL | 5700 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | FILM / BUCCAL | 1.48 mg | ||
| sodium benzoate | SODIUM BENZOATE | OJ245FE5EU | SYRUP / ORAL | 80 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION / ORAL | 26208 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | TABLET / PERIODONTAL | 0.53 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / ORAL | 32400 mg | ||
| sodium benzoate | SODIUM BENZOATE | OJ245FE5EU | TABLET, EXTENDED RELEASE / ORAL | NA | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL / TOPICAL | 19.2 %w/w | ||
| sodium metabisulfite | SODIUM METABISULFITE | 4VON5FNS3C | INJECTION, EMULSION / INTRAVENOUS | 0.03 %w/v | ||
| sorbitol | SORBITOL | 506T60A25R | CAPSULE / ORAL | 1111 mg | ||
| sorbitol | SORBITOL | 506T60A25R | INJECTION / INTRA-ARTICULAR | 45 %w/v | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, SOLUTION / INTRAMUSCULAR | 4000 mg | ||
| sorbitol | SORBITOL | 506T60A25R | SPRAY / NASAL | 49 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION, CONCENTRATE / ORAL | 2590 mg | ||
| sorbitol | SORBITOL | 506T60A25R | PASTE / DENTAL | 14.6 %w/w | ||
| sodium benzoate | SODIUM BENZOATE | OJ245FE5EU | SPONGE / TOPICAL | NA | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SYSTEM / TOPICAL | 4200 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | JELLY / VAGINAL | NA | ||
| sodium metabisulfite | SODIUM METABISULFITE | 4VON5FNS3C | INJECTION, SOLUTION / SUBMUCOSAL | 5 %w/v | ||
| phosphoric acid | PHOSPHORIC ACID | E4GA8884NN | OINTMENT / TOPICAL | ADJ PH | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SPONGE / TOPICAL | 2 %w/w | ||
| sorbitol | SORBITOL | 506T60A25R | POWDER, FOR SUSPENSION / ORAL | 12000 mg | ||
| sodium metabisulfite | SODIUM METABISULFITE | 4VON5FNS3C | INJECTION / INTRACARDIAC | 0.09 %w/v | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / AURICULAR (OTIC) | 10 %w/v | ||
| sodium metabisulfite | SODIUM METABISULFITE | 4VON5FNS3C | INJECTION / INFILTRATION | 0.5 %w/v | ||
| phosphoric acid | PHOSPHORIC ACID | E4GA8884NN | TABLET, ORALLY DISINTEGRATING / ORAL | 4 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 63.4 %w/v | ||
| sorbitol | SORBITOL | 506T60A25R | TABLET / SUBLINGUAL | 50.5 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION / OPHTHALMIC | 58 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, FILM COATED / ORAL | 96 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION / SUBCUTANEOUS | 1.4 %w/v | ||
| glycerin | GLYCERIN | PDC6A3C0OX | GEL / TRANSDERMAL | 500 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION/ DROPS / AURICULAR (OTIC) | 25 mg | ||
| sodium metabisulfite | SODIUM METABISULFITE | 4VON5FNS3C | SOLUTION / RESPIRATORY (INHALATION) | 0.3 %w/w | ||
| phosphoric acid | PHOSPHORIC ACID | E4GA8884NN | TABLET / ORAL | 0.04 mg | ||
| sorbitol | SORBITOL | 506T60A25R | LIQUID / ORAL | 53460 mg | ||
| sodium benzoate | SODIUM BENZOATE | OJ245FE5EU | GEL / RECTAL | 406 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | PASTE / DENTAL | 0.5 %w/w | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | LIQUID / RESPIRATORY (INHALATION) | 10 %w/w | ||
| glycerin | GLYCERIN | PDC6A3C0OX | PASTE / ORAL | 3822 mg | ||
| sodium phosphate, monobasic, dihydrate | SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE | 5QWK665956 | INJECTION / SUBCUTANEOUS | 0.3 %w/v | ||
| glycerin | GLYCERIN | PDC6A3C0OX | INJECTION / INTRAMUSCULAR | 450 mg | ||
| phosphoric acid | PHOSPHORIC ACID | E4GA8884NN | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | ADJ PH | ||
| glycerin | GLYCERIN | PDC6A3C0OX | TABLET / ORAL | 42 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / OPHTHALMIC | 0.44 %w/w | ||
| sodium benzoate | SODIUM BENZOATE | OJ245FE5EU | FILM, SOLUBLE / BUCCAL | 3 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / SUBCUTANEOUS | 15 %w/v | ||
| sodium phosphate, monobasic, dihydrate | SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE | 5QWK665956 | INJECTION, SOLUTION / INTRATHECAL | 0.01 %w/v | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / OPHTHALMIC | 2.5 %w/v | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / RESPIRATORY (INHALATION) | 5 %w/w | ||
| sorbitol | SORBITOL | 506T60A25R | SYRUP / ORAL | 4370 mg/5ml | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / NASAL | 25 mg/1ml | ||
| sodium phosphate, monobasic, dihydrate | SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE | 5QWK665956 | INJECTION / INTRAVENOUS | 12.8 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | DOUCHE / VAGINAL | 1 %w/w | ||
| glycerin | GLYCERIN | PDC6A3C0OX | TABLET, CHEWABLE / ORAL | 12 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION/ DROPS / OPHTHALMIC | 12 mg | ||
| sorbitol | SORBITOL | 506T60A25R | INJECTION / INTRAMUSCULAR | NA | ||
| sodium phosphate, monobasic, dihydrate | SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE | 5QWK665956 | SOLUTION / OPHTHALMIC | 2 mg | ||
| sodium phosphate, monobasic, dihydrate | SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE | 5QWK665956 | SUSPENSION / ORAL | 140 mg | ||
| phosphoric acid | PHOSPHORIC ACID | E4GA8884NN | INJECTION / SUBCUTANEOUS | ADJ PH |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076805-001 | LORATADINE | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 |
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | f41ea6bd6efb… |
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 |
|---|---|---|---|---|---|---|
| b46093d4-340a-444a-a9ad-d3e8022f8eb8 | 1cd1d710-0c4d-49ef-8b7d-daac8597b2a9 | 2015-04-20 | Warnings | b46093d4-340a-444a-a9ad-d3e8022f8eb8 1cd1d710-0c4d-49ef-8b7d-daac8597b2a9 |
Adverse event summaries are temporarily unavailable. Other product information remains available.