FDA.reportPublic FDA data

Dimetapp

Manufacturer
Foundation Consumer Healthcare
Effective date
2024-04-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:11:00

Label at a glance#

ProductDimetapp Cough and Allergy
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

temporarily relieves: cough runny nose sneezing itching of the nose or throat itchy, watery eyes due to hay fever temporarily alleviates the intensity of coughing

Dosage and administration

chew or crush tablets completely before swallowing, do not swallow tablets whole do not take more than 6 doses in 24 hours age dose adults and children 12 years and over take 2 tablets every 4 hours not to exceed 12 tablets in 24 hours children 6 to under 12 years take 1 tablet every 4 hours not to exceed 6 tablets in 24 hours children under 6 years do not use

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 12.5 mg

OTC - PURPOSE SECTION

Active ingredients (in each chewable tablet)Purposes
Diphenhydramine HCl 12.5 mgAntihistamine/Cough suppresant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves:
    • cough
    • runny nose
    • sneezing
    • itching of the nose or throat
    • itchy, watery eyes due to hay fever
  • temporarily alleviates the intensity of coughing

WARNINGS SECTION

Warnings

Do not use

OTC - DO NOT USE SECTION

  • to sedate a child or make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • glaucoma
  • trouble urinating due to enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • may cause marked drowsiness
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a vehicle or operating machinery
  • excitability may occur, expecially in children

Stop use and ask a doctor if

OTC - STOP USE SECTION

cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • chew or crush tablets completely before swallowing, do not swallow tablets whole
  • do not take more than 6 doses in 24 hours
agedose
adults and children 12 years and overtake 2 tablets every 4 hours not to exceed 12 tablets in 24 hours
children 6 to under 12 yearstake 1 tablet every 4 hours not to exceed 6 tablets in 24 hours
children under 6 yearsdo not use

Other information

OTHER SAFETY INFORMATION

  • store at 20-25°C (68-77°​F)
  • avoid high humidity

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C red no.27 aluminum lake, D&C red no.30 aluminum lake, dextrates hydrated, ethylcellulose, FD&C blue no.1 aluminum lake, flavor, hydroxypropyl cellulose, magnesium stearate, mannitol, modified corn starch, stearic acid, sucralose, sucrose

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-888-594-0828weekdays 9 AM to 5PM EST

SPL UNCLASSIFIED SECTION

Distributed by:

Foundation Consumer Healthcare, LLC

Pittsburgh, PA 15212

PRINCIPAL DISPLAY PANEL - 24 ct Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CHILDREN'S

Dimetapp

DIPHENHYDRAMINE HCl, 12.5 mg

(Antihistamine/Cough Suppressant)

GREAT CHEWABLE TASTE

Cough & Allergy

Relieves + comforts:

  • Cough
  • Itchy throat
  • Sneezing
  • Runny nose

6+ years

24 CHEWABLE TABLETS

Grape-Flavored

Dimetapp - 24ct CartonDimetapp - 24ct Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049900diphenhydrAMINE HCl 12.5 MG Chewable TabletPSN2
1049900diphenhydramine hydrochloride 12.5 MG Chewable TabletSCD2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69536-370-24DimetappCough and Allergy6 in 1 BLISTER PACKTABLET, CHEWABLE62
69536-370-24DimetappCough and Allergy4 in 1 CARTONTABLET, CHEWABLE42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69536-370DIMETAPP COUGH AND ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, CHEWABLE [FOUNDATION CONSUMER HEALTHCARE]2Current NDC, 2 package rows20240415_15b0f5ff-202a-d19f-e063-6394a90af2b8.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69536-37069536-370-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C BLUE NO. 1 ALUMINUM LAKEJ9EQA3S2JMIACT
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)461P5CJN6TIACT
SUCRALOSE96K6UQ3ZD4IACT
SUCROSEC151H8M554IACT
D&C RED NO. 302S42T2808BIACT
MAGNESIUM STEARATE70097M6I30IACT
D&C RED NO. 27 ALUMINUM LAKEZK64F7XSTXIACT
DEXTRATESG263MI44RUIACT
ETHYLCELLULOSE, UNSPECIFIED7Z8S9VYZ4BIACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED9XZ8H6N6OHIACT
MANNITOL3OWL53L36AIACT
STEARIC ACID4ELV7Z65APIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB

Source Document#

Source XML

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
Dimetapp Cough and AllergyDIPHENHYDRAMINE HYDROCHLORIDEFoundation Consumer Healthcare15b0f5ff-202a-d19f-e063-6394a90af2b82024-04-15WarningsExact identifier
ndc (package): 69536-370-24
ndc (product): 69536-370
ndc11 (package): 69536037024
spl id: 15d9c0b3-b510-242a-e063-6294a90a3946
spl set id: 15b0f5ff-202a-d19f-e063-6394a90af2b8

Reported adverse events (FAERS/openFDA)#

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