Storage and handling
Other information do not use if solution is brown or contains a precipitate protect from light store at 20-25 o C (68-77 o F) see bottle or box for lot number and expiration date
Other information do not use if solution is brown or contains a precipitate protect from light store at 20-25 o C (68-77 o F) see bottle or box for lot number and expiration date
Active ingredient Purpose
Phenylephrine Hydrochloride USP 0.125%...................Nasal Decongestant
Uses
Warnings
Ask a doctor before use if the child has
When using this product temporary discomfort may occur such as:
Stop use and ask a doctor if
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions (Nasal use only)
Other information
Inactive ingredients
Benzalkonium Chloride, Edetate Disodium, Glycerin, Polyethylene Glycol, Potassium Phosphate Monobasic, Purified Water, Sodium Phosphate Dibasic
Enter section text here
| Class | Version | Type | Effective |
|---|---|---|---|
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e4e263da-1c53-440f-bb80-b7a575843b5a | Product name | 1 | 20260313 |
| d2168cac-a261-415a-9c78-3522859fa720 | Product name | 3 | 20251124 |
| 05a8cdd1-eeb8-409e-b938-0778225eca7d | Product name | 4 | 20250221 |
| e5b5c132-b15d-435b-9faa-2f74e5cadcf9 | Product name | 8 | 20250220 |
| f489e8f3-5c9e-4818-b539-a73587edcfc7 | Product name | 2 | 20240229 |
| 0f7ae452-206d-4fc4-868d-56fc47074084 | Product name | 1 | 20231011 |
| b5abe2e3-39a1-43eb-9bff-f3c1653fe3df | Product name | 2 | 20190930 |
| e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814 | Product name | 3 | 20150910 |
| 42f3c020-f1b3-89bc-7bdc-e1f10e680485 | Product name | 1 | 20140508 |
| e949165d-714d-e548-2b76-0cb5def16f30 | Product name | 1 | 20140508 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68169-9930-6 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-dd0a-621f-e053-dbdaa90a74ad | Drug Facts |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68169-9930-6 | CVS CHILDREN DECONGESTANT NOSE DROPS | 1 in 1 CARTON | SOLUTION | 1 | 2 | |
| 68169-9930-6 | CVS CHILDREN DECONGESTANT NOSE DROPS | 15 mL in 1 BOTTLE | SOLUTION | 15 | 2 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68169-9930 | CVS CHILDREN DECONGESTANT NOSE DROPS (PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [TAI GUK PHARM. CO., LTD.] | 2 | Legacy NDC, 2 package rows | 20100715_84ef5ce2-76f8-4209-9c7b-25296cf109a4.zip |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| PHENYLEPHRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 04JA59TNSJ | 2 | |
| PHENYLEPHRINE | ACTIVE MOIETY | 1WS297W6MV | 2 | |
| BENZALKONIUM CHLORIDE | INACTIVE INGREDIENT | F5UM2KM3W7 | 2 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | 2 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 2 | |
| POLYETHYLENE GLYCOL | INACTIVE INGREDIENT | 3WJQ0SDW1A | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 68169-9930 | 68169-9930-6 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
| BENZALKONIUM CHLORIDE | F5UM2KM3W7 | IACT |
| EDETATE DISODIUM | 7FLD91C86K | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| POLYETHYLENE GLYCOL | 3WJQ0SDW1A | IACT |
| WATER | 059QF0KO0R | 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 |
|---|---|---|---|---|---|---|
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SPONGE / TOPICAL | 2 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE, COATED / ORAL | 14.21 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / ORAL | 750 mg | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | SOLUTION/ DROPS / AURICULAR (OTIC) | 0 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | EMULSION / OPHTHALMIC | 3 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / RECTAL | 97 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | CREAM, AUGMENTED / TOPICAL | 2 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SYSTEM / IONTOPHORESIS | 168.1 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / INTRAVENOUS | 33750 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / ORAL | 432 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | GEL / VAGINAL | 5 mg | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | SPRAY / NASAL | 1 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SPRAY / NASAL | 1 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | DROPS / ORAL | 300 mg/1ml | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | LOTION / TOPICAL | 0.1 %w/w | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | CLOTH / TOPICAL | NA | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / SUBCUTANEOUS | 6 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / TOPICAL | 1 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | ELIXIR / ORAL | 1.3 mg/5ml | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | GEL / OPHTHALMIC | 0.01 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | TABLET, ORALLY DISINTEGRATING / ORAL | 3 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS | 0.4 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / INTRADERMAL | 1.6 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | AEROSOL, FOAM / TOPICAL | 21 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | TABLET, FILM COATED / ORAL | 4 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRAVENOUS | 10 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE / ORAL | 3822 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / OPHTHALMIC | 6 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | DROPS / OPHTHALMIC | 0.05 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | OINTMENT / TOPICAL | NA | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | SOLUTION/ DROPS / OPHTHALMIC | 1 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | DROPS / AURICULAR (OTIC) | 0.05 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SYSTEM / IONTOPHORESIS | 0.1 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | CAPSULE / ORAL | 5 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GEL / OPHTHALMIC | 0.88 %w/w | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | SOLUTION / TOPICAL | 0.02 %w/v | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | INJECTION / INTRA-ARTICULAR | 1 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | OINTMENT / TOPICAL | 1 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SPRAY / RESPIRATORY (INHALATION) | 0.05 %w/w | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | SUSPENSION/ DROPS / TOPICAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, EXTENDED RELEASE / ORAL | 7 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | LOTION / TOPICAL | 22 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | GEL / TRANSDERMAL | 1 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, CHEWABLE / ORAL | 12 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SYSTEM / TOPICAL | 18144 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / ORAL | 26208 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRA-ARTICULAR | 0.05 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / RESPIRATORY (INHALATION) | 43 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / DENTAL | 15 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION, SUSPENSION / SOFT TISSUE | 1 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION, SOLUTION / INTRAMUSCULAR | 4 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION, SOLUTION / SUBCUTANEOUS | 2 mg | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | INJECTION / INTRAMUSCULAR | 1 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION/ DROPS / AURICULAR (OTIC) | 25 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | DROPS / NASAL | 10 mg/1ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, EMULSION / INTRAVENOUS | 24100 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CLOTH / TOPICAL | 0.05 mg/mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 19 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE, LIQUID FILLED / ORAL | 185 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | LIQUID / ORAL | 2400 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 |
|---|---|---|---|---|---|---|
| 4a7f4a56-1609-4ae0-9a2f-ff15d47cec32 | 84ef5ce2-76f8-4209-9c7b-25296cf109a4 | 2010-07-12 | Warnings | 4a7f4a56-1609-4ae0-9a2f-ff15d47cec32 84ef5ce2-76f8-4209-9c7b-25296cf109a4 |
Adverse event summaries are temporarily unavailable. Other product information remains available.