Dibromm Cold and Allergy

Manufacturer
QUALITY CHOICE (Chain Drug Marketing Association)
Effective date
2024-04-22
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:11:19

Label at a glance#

ProductDibromm Cold and Allergy Childrens
Active ingredientBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily relieves these symptoms due to hay fever (allergic rhinitis) runny nose itchy, watery eyes sneezing itching of the nose or throat temporarily restores freer breathing through the nose  ​​​

Dosage and administration

do not take more than 6 doses in any 24-hour period  measure only with dosing cup provided. Do not use any other dosing device. keep dosing cup with product mL = milliliter  age  dose adults and children 12 years and over 20 mL every 4 hours  children 6 to 11 years  10 mL every 4 hours  children under 6 years do not use

Storage and handling

each 10 mL contains : sodium 6 mg store between 20-25°C (68-77°F). Do not refrigerate. 

Label contents#

Full prescribing information#

Active ingredients (in each 10 mL)

OTC - ACTIVE INGREDIENT SECTION

Brompheniramine maleate 2 mg

Phenylephrine HCI 5 mg

Purposes

OTC - PURPOSE SECTION

Antihistamine

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • temporarily relieves these symptoms due to hay fever (allergic rhinitis)
    • runny nose
    • itchy, watery eyes
    • sneezing
    • itching of the nose or throat
  • temporarily restores freer breathing through the nose

 ​​​

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • to sedate a child or to make a child sleepy
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • heart disease
  • high blood pressure
  • glaucoma
  • diabetes
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking any other oral nasal decongestant or stimulant
  • taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • do not use more than directed
  • drowsiness may occur
  • avoid alcoholic beverages
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

Stop use and ask a doctor if

SPL UNCLASSIFIED SECTION

  • nervousness, dizziness or sleeplessness occur
  • symptoms do not get better within 7 days or are accompanied by fever

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

 ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than 6 doses in any 24-hour period 
  • measure only with dosing cup provided. Do not use any other dosing device.
  • keep dosing cup with product
  • mL = milliliter
 age dose
adults and children 12 years and over20 mL every 4 hours
 children 6 to 11 years 10 mL every 4 hours
 children under 6 yearsdo not use

Other information

STORAGE AND HANDLING SECTION

  • each 10 mL contains: sodium 6 mg
  • store between 20-25°C (68-77°F). Do not refrigerate. 

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, FD&C blue #1, FD&C red # 40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-935-2362 Monday-Friday 9AM-5PM EST 

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

*Compare to the active ingredients in Children's Dimetapp® Cold & Allergy

Children's

Dibromm

Cold & Allergy

Brompheniramine Maleate

Antihistamine

Phenylephrine HCI

Nasal Decongestant

For Ages 6 years & Over

Alcohol free

Grape Flavor

FL OZ (mL)

*This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributors of Children's Dimetapp® Cold & Allergy.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

Distributed by: CDMA, Inc.

Novi, MI 48375

www.qualitychoice.com

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

QUALITY CHOICE Cold and Allergy Grape Flavor
QUALITY CHOICE Cold and Allergy Grape Flavor

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1053258brompheniramine maleate 1 MG / phenylephrine HCl 2.5 MG in 5 mL Oral SolutionPSN6
1053258brompheniramine maleate 0.2 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCD6
1053258brompheniramine maleate 1 MG / phenylephrine HCl 2.5 MG per 5 ML Oral ElixirSY6
1053258brompheniramine maleate 1 MG / phenylephrine HCl 2.5 MG per 5 ML Oral SolutionSY6
1053258brompheniramine maleate 2 MG / phenylephrine HCl 5 MG per 10 ML Oral SolutionSY6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-241-04Dibromm Cold and AllergyChildrens118 mL in 1 BOTTLE, PLASTICLIQUID1186
63868-241-04Dibromm Cold and AllergyChildrens1 in 1 BOXLIQUID16
63868-241-08Dibromm Cold and AllergyChildrens1 in 1 BOXLIQUID16
63868-241-08Dibromm Cold and AllergyChildrens237 mL in 1 BOTTLE, PLASTICLIQUID2376

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-241DIBROMM COLD AND ALLERGY CHILDRENS (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]6Current NDC, Legacy NDC, 4 package rows20240423_ea285d5a-9eb4-4f71-bb1b-4e24a8972819.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-241-04ML - Milliliter63868-241fc8bbbfe-d36c-4038-963c-bce9caf0414712022-09-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BROMPHENIRAMINE MALEATEACTIVE INGREDIENTIXA7C9ZN031
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJ1
BROMPHENIRAMINEACTIVE MOIETYH57G17P2FN1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MV1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSL1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU1
SORBITOLINACTIVE INGREDIENT506T60A25R1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD41
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95K1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63868-24163868-241-08, 63868-241-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

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.

Inactive ingredient links page 1 of 5 · 297 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSOLUTION / ORAL660 mgExact identifier — unii+route
57 equally ranked IID candidates
TRISODIUM CITRATE DIHYDRATETRISODIUM CITRATE DIHYDRATEB22547B95KTABLET, DELAYED RELEASE / ORAL640 mgExact identifier — unii+route
42 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOAPOWDER, FOR SUSPENSION / ORAL3 mgExact identifier — unii+route
66 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION, EXTENDED RELEASE / ORAL62 mgExact identifier — unii+route
66 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION / ORAL3900 mgExact identifier — unii+route
66 equally ranked IID candidates
TRISODIUM CITRATE DIHYDRATETRISODIUM CITRATE DIHYDRATEB22547B95KCAPSULE / ORAL35 mgExact identifier — unii+route
42 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4POWDER, FOR SOLUTION / ORAL414 mgExact identifier — unii+route
54 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACONCENTRATE / ORAL0.04 mg/1mlExact identifier — unii+route
66 equally ranked IID candidates
TRISODIUM CITRATE DIHYDRATETRISODIUM CITRATE DIHYDRATEB22547B95KPOWDER, FOR SUSPENSION / ORAL5010 mgExact identifier — unii+route
42 equally ranked IID candidates
TRISODIUM CITRATE DIHYDRATETRISODIUM CITRATE DIHYDRATEB22547B95KSUSPENSION / ORAL5013 mgExact identifier — unii+route
42 equally ranked IID candidates
TRISODIUM CITRATE DIHYDRATETRISODIUM CITRATE DIHYDRATEB22547B95KCONCENTRATE / ORAL104 mgExact identifier — unii+route
42 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, DELAYED RELEASE PELLETS / ORAL0.02 mgExact identifier — unii+route
66 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, COATED / ORALNAExact identifier — unii+route
66 equally ranked IID candidates
TRISODIUM CITRATE DIHYDRATETRISODIUM CITRATE DIHYDRATEB22547B95KTABLET, DELAYED RELEASE / ORAL640 mgExact identifier — unii+route
42 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET, ORALLY DISINTEGRATING / ORAL46 mgExact identifier — unii+route
66 equally ranked IID candidates
TRISODIUM CITRATE DIHYDRATETRISODIUM CITRATE DIHYDRATEB22547B95KTABLET, CHEWABLE / ORAL14 mgExact identifier — unii+route
42 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION/ DROPS / ORAL15 mgExact identifier — unii+route
66 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET / ORAL30 mgExact identifier — unii+route
57 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLELIXIR / ORAL90 mgExact identifier — unii+route
66 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUPOWDER, FOR SUSPENSION / ORAL160 mgExact identifier — unii+route
57 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, DELAYED RELEASE / ORAL2 mgExact identifier — unii+route
66 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SUSPENSION / ORAL383 mgExact identifier — unii+route
54 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET, ORALLY DISINTEGRATING / ORAL46 mgExact identifier — unii+route
66 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SYRUP / ORAL80 mgExact identifier — unii+route
54 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, EFFERVESCENT / ORAL1080 mgExact identifier — unii+route
54 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASYRUP / ORAL3 mgExact identifier — unii+route
66 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDLIQUID / ORALNAExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, LIQUID FILLED / ORAL1 mgExact identifier — unii+route
66 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, LIQUID FILLED / ORAL1 mgExact identifier — unii+route
66 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLCAPSULE, LIQUID FILLED / ORAL360 mgExact identifier — unii+route
66 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASOLUTION / ORAL38 mgExact identifier — unii+route
66 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, COATED PELLETS / ORALNAExact identifier — unii+route
66 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION/ DROPS / ORAL23 mgExact identifier — unii+route
57 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET / ORAL7 mgExact identifier — unii+route
66 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLCONCENTRATE / ORAL84 mgExact identifier — unii+route
66 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION / ORAL320 mgExact identifier — unii+route
57 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION / ORAL3900 mgExact identifier — unii+route
66 equally ranked IID candidates
TRISODIUM CITRATE DIHYDRATETRISODIUM CITRATE DIHYDRATEB22547B95KELIXIR / ORAL120 mgExact identifier — unii+route
42 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, ORALLY DISINTEGRATING / ORAL60 mgExact identifier — unii+route
54 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, COATED / ORAL0.2 mgExact identifier — unii+route
57 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION/ DROPS / ORAL23 mgExact identifier — unii+route
57 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, COATED PELLETS / ORALNAExact identifier — unii+route
66 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4LOZENGE / ORAL115 mgExact identifier — unii+route
54 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LIQUID / ORAL29008 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4POWDER, FOR SOLUTION / ORAL414 mgExact identifier — unii+route
54 equally ranked IID candidates
TRISODIUM CITRATE DIHYDRATETRISODIUM CITRATE DIHYDRATEB22547B95KTABLET, CHEWABLE / ORAL14 mgExact identifier — unii+route
42 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOAPOWDER, FOR SOLUTION / ORAL0.33 mg/5mlExact identifier — unii+route
66 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCONCENTRATE / ORAL20 mgExact identifier — unii+route
57 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4LOZENGE / ORAL115 mgExact identifier — unii+route
54 equally ranked IID candidates
TRISODIUM CITRATE DIHYDRATETRISODIUM CITRATE DIHYDRATEB22547B95KSYRUP / ORAL705 mgExact identifier — unii+route
42 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4GRANULE / ORAL5.4 mgExact identifier — unii+route
54 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASOLUTION / ORAL38 mgExact identifier — unii+route
66 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET, EXTENDED RELEASE / ORAL2.22 mgExact identifier — unii+route
66 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASUSPENSION/ DROPS / ORAL1 mgExact identifier — unii+route
66 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLCAPSULE / ORAL131 mgExact identifier — unii+route
66 equally ranked IID candidates
TRISODIUM CITRATE DIHYDRATETRISODIUM CITRATE DIHYDRATEB22547B95KCAPSULE / ORAL35 mgExact identifier — unii+route
42 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SUSPENSION, EXTENDED RELEASE / ORAL16 mgExact identifier — unii+route
54 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASUSPENSION/ DROPS / ORAL1 mgExact identifier — unii+route
66 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, FOR SUSPENSION / ORAL65 mgExact identifier — unii+route
54 equally ranked IID candidates

openFDA label cross-check#

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dibromm Cold and Allergy ChildrensBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCLQUALITY CHOICE (Chain Drug Marketing Association)ea285d5a-9eb4-4f71-bb1b-4e24a89728192024-04-22WarningsExact identifier
ndc (package): 63868-241-08
ndc (package): 63868-241-04
ndc (product): 63868-241
ndc11 (package): 63868024104
ndc11 (package): 63868024108
spl id: 6f5a82da-9dbb-4767-b988-6ed771eb3b57
spl set id: ea285d5a-9eb4-4f71-bb1b-4e24a8972819

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.