Indications and uses
temporarily relieves: sneezing runny nose itchy nose or throat itchy, watery eyes due to hay fever nasal and sinus congestion cough due to minor throat and bronchial irritation as may occur with a cold
temporarily relieves: sneezing runny nose itchy nose or throat itchy, watery eyes due to hay fever nasal and sinus congestion cough due to minor throat and bronchial irritation as may occur with a cold
Do not give more than 6 doses in 24 hours unless directed by a doctor. measure only with dosing cup provided. Do not use any other dosing device. keep dosing cup with product mL = milliliter shake well before using age dose children 6 to under 12 years 10 mL every 4 hours children 4 to under 6 years do not use unless directed by a doctor children under 4 years of age do not use
each 5 mL contains : sodium 3 mg store between 20-25°C (68-77°F). Do not refrigerate protect from light
Diphenhydramine HCl 6.25 mg
Phenylephrine HCl 2.5 mg
Antihistamine/Cough suppressant
Nasal decongestant
taking sedatives or tranquilizers
These could be signs of a serious condition.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
| age | dose |
| children 6 to under 12 years | 10 mL every 4 hours |
| children 4 to under 6 years | do not use unless directed by a doctor |
| children under 4 years of age | do not use |
acesulfame potassium, anhydrous citric acid, EDTA disodium, FD&C blue #1, FD&C red #40, flavor, maltitol, propylene glycol, purified water, sodium benzoate, trisodium citrate dihydrate
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Compare to the active ingredients in Children's Triaminic® Nighttime Cold & Cough
children's triacting nighttime
Cold & Cough
Diphenhydramine HCl 6.25 mg
Phenylephrine HCl 2.5 mg
antihistamine/
cough suppressant
nasal decongestant
relieves:
for ages 6 to 11
Grape Flavor
FL OZ (mL)
*This product is not manufactured or distributed by GSK Consumer Healthcare, distributors of Children's Triaminic® Night Time Cold & Cough.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER THE CAP IS BROKEN OR MISSING.
Manufactured by:
PL Developments
11865 S. Alameda St
Lynwood, CA 90262
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1236048 | diphenhydrAMINE HCl 6.25 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution | PSN | 7 |
| 1236048 | diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution | SCD | 7 |
| 1236048 | diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution | SY | 7 |
| 1236048 | diphenhydramine HCl 6.25 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Solution | SY | 7 |
| Class | Version | Type | Effective |
|---|---|---|---|
| DIPHENHYDRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| 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 |
| 0e2e0f88-b076-afe1-4bdd-32bca4375bec | Product name | 3 | 20250127 |
| 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 |
| 3e48c9c4-918d-5d23-2f0b-d2398b06be54 | Product name | 1 | 20140508 |
| 42f3c020-f1b3-89bc-7bdc-e1f10e680485 | Product name | 1 | 20140508 |
| 865c72dd-0d94-daac-f728-ddd4ded2a79e | Product name | 1 | 20140508 |
| e949165d-714d-e548-2b76-0cb5def16f30 | Product name | 1 | 20140508 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49580-0379-4 | Childrens Triacting NighttimeCold and Cough ReadyInCase | 1 in 1 BOX | LIQUID | 1 | 7 | |
| 49580-0379-4 | Childrens Triacting NighttimeCold and Cough ReadyInCase | 118 mL in 1 BOTTLE, PLASTIC | LIQUID | 118 | 7 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 49580-0379 | CHILDRENS TRIACTING NIGHTTIME COLD AND COUGH READYINCASE (DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [P & L DEVELOPMENT, LLC] | 7 | Legacy NDC, 2 package rows | 20231014_61980e57-5b94-4ae2-8e08-848749e4abcd.zip |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | ACTIVE INGREDIENT | TC2D6JAD40 | 1 | |
| PHENYLEPHRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 04JA59TNSJ | 1 | |
| DIPHENHYDRAMINE | ACTIVE MOIETY | 8GTS82S83M | 1 | |
| PHENYLEPHRINE | ACTIVE MOIETY | 1WS297W6MV | 1 | |
| ACESULFAME POTASSIUM | INACTIVE INGREDIENT | 23OV73Q5G9 | 1 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | 1 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | 1 | |
| MALTITOL | INACTIVE INGREDIENT | D65DG142WK | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | 1 | |
| TRISODIUM CITRATE DIHYDRATE | INACTIVE INGREDIENT | B22547B95K | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 49580-0379 | 49580-0379-4 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
| DIPHENHYDRAMINE HYDROCHLORIDE | TC2D6JAD40 | ACTIB |
| ACESULFAME POTASSIUM | 23OV73Q5G9 | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| EDETATE DISODIUM | 7FLD91C86K | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| TRISODIUM CITRATE DIHYDRATE | B22547B95K | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| MALTITOL | D65DG142WK | 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 |
|---|---|---|---|---|---|---|
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | AEROSOL, FOAM / TOPICAL | 0.05 %w/w | ||
| TRISODIUM CITRATE DIHYDRATE | TRISODIUM CITRATE DIHYDRATE | B22547B95K | SUSPENSION/ DROPS / OPHTHALMIC | 7 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | CONCENTRATE / ORAL | 20 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | FILM / SUBLINGUAL | 11 mg | ||
| TRISODIUM CITRATE DIHYDRATE | TRISODIUM CITRATE DIHYDRATE | B22547B95K | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 200 mg | ||
| TRISODIUM CITRATE DIHYDRATE | TRISODIUM CITRATE DIHYDRATE | B22547B95K | TABLET, DELAYED RELEASE / ORAL | 640 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | FILM, EXTENDED RELEASE / TRANSDERMAL | 58.13 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION/ DROPS / OPHTHALMIC | 0.75 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRALESIONAL | 0.05 %w/v | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SUSPENSION / RECTAL | 904 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SOLUTION / OPHTHALMIC | 0.09 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE / ORAL | 1072 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, FOAM / VAGINAL | 6.4 %w/w | ||
| TRISODIUM CITRATE DIHYDRATE | TRISODIUM CITRATE DIHYDRATE | B22547B95K | SOLUTION / INTRAOCULAR | 27 mg | ||
| ACESULFAME POTASSIUM | ACESULFAME POTASSIUM | 23OV73Q5G9 | TABLET / ORAL | 111 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | TABLET, CHEWABLE / ORAL | 4 mg | ||
| MALTITOL | MALTITOL | D65DG142WK | FILM, SOLUBLE / ORAL | 44 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / OPHTHALMIC | 0.6 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SPRAY / SUBLINGUAL | 36 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | TABLET, DELAYED RELEASE / ORAL | 100 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | GEL / TRANSDERMAL | 1 mg | ||
| ACESULFAME POTASSIUM | ACESULFAME POTASSIUM | 23OV73Q5G9 | TABLET, FILM COATED / ORAL | 1.75 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SUSPENSION / ORAL | 400 mg | ||
| ACESULFAME POTASSIUM | ACESULFAME POTASSIUM | 23OV73Q5G9 | SOLUTION / DENTAL | 0.12 %w/w | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | POWDER, FOR SUSPENSION / ORAL | 3 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT / RECTAL | 27 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | TABLET / ORAL | 30 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | FILM, SOLUBLE / ORAL | 0.04 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SPRAY / NASAL | 5 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION, SUSPENSION / SOFT TISSUE | 1 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | TABLET, EXTENDED RELEASE / ORAL | NA | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | INJECTION / INTRAVENOUS | 864 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION / ORAL | 30 mg | ||
| TRISODIUM CITRATE DIHYDRATE | TRISODIUM CITRATE DIHYDRATE | B22547B95K | SUSPENSION, EXTENDED RELEASE / ORAL | 9 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SHAMPOO, SUSPENSION / TOPICAL | 2 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | TABLET, EFFERVESCENT / ORAL | 32 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOAP / TOPICAL | 0.01 %w/w | ||
| TRISODIUM CITRATE DIHYDRATE | TRISODIUM CITRATE DIHYDRATE | B22547B95K | INJECTION / INTRAVENOUS | 3480 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SUSPENSION / ORAL | 100 mg/5ml | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 63.4 %w/v | ||
| ACESULFAME POTASSIUM | ACESULFAME POTASSIUM | 23OV73Q5G9 | FILM / SUBLINGUAL | 5 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | TABLET, COATED / ORAL | 0.21 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | GEL / OPHTHALMIC | 396 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | PASTE, DENTIFRICE / DENTAL | 0.5 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, DELAYED RELEASE / ORAL | 1.7 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | LIQUID / ORAL | NA | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRACARDIAC | 2 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, CHEWABLE / ORAL | 40 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, SOLUTION / INTRAVENOUS | 4000 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / RESPIRATORY (INHALATION) | 43 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / RECTAL | 90400 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CONCENTRATE / ORAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SYRUP / ORAL | 0.05 mg/5ml | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | TABLET, FILM COATED / ORAL | 1 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SPRAY / NASAL | 5 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | DROPS / NASAL | 0.1 mg/1ml | ||
| TRISODIUM CITRATE DIHYDRATE | TRISODIUM CITRATE DIHYDRATE | B22547B95K | INJECTION / INTRACARDIAC | 21 mg | ||
| TRISODIUM CITRATE DIHYDRATE | TRISODIUM CITRATE DIHYDRATE | B22547B95K | CAPSULE / ORAL | 35 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION, EXTENDED RELEASE / ORAL | 1000 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 |
|---|---|---|---|---|---|---|
| f4d797cd-2bcd-41e6-b683-93d70e31da64 | 61980e57-5b94-4ae2-8e08-848749e4abcd | 2023-10-13 | Warnings | f4d797cd-2bcd-41e6-b683-93d70e31da64 61980e57-5b94-4ae2-8e08-848749e4abcd |
Adverse event summaries are temporarily unavailable. Other product information remains available.