FDA.reportPublic FDA data

Rompe Pechito Allergy for Kids

Manufacturer
Efficient Laboratories, Inc. | RNV, LLC
Effective date
2026-09-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-09-19 01:01:05

Label at a glance#

ProductRompe Pechito Allergy for Kids
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure14 sections

Indications and uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose, sneezing, itchy watery eyes, itching of the nose or throat

Dosage and administration

find the right dose on chart below; mL=milliliter take every 4 to 6 hours, or as directed by a doctor do not take more than 6 doses in 24 hours use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device age dose children 6 to 11 years 5 mL (1 teaspoonful) to 10 mL (2 teaspoonful) children 2 to 5 years do not use unless directed by a doctor children under 2 year...

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 12.5 mg (in each 5 mL)

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose, sneezing, itchy watery eyes, itching of the nose or throat

Do not use

OTC - DO NOT USE SECTION

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

Ask a doctor before use if the child has

OTC - ASK DOCTOR SECTION

  • a breathing problem such as chronic bronchitis
  • glaucoma

Ask a doctor or pharmacist

OTC - ASK DOCTOR/PHARMACIST SECTION

before use if the child is taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness
  • excitability may occur, especially in children

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 right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

  • find the right dose on chart below; mL=milliliter
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 doses in 24 hours
  • use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device
agedose
children 6 to 11 years5 mL (1 teaspoonful) to 10 mL (2 teaspoonful)
children 2 to 5 yearsdo not use unless directed by a doctor
children under 2 yearsdo not use

Other information

OTHER SAFETY INFORMATION

  • store between 15-30°C (59-86°F)
  • do not refrigerate
  • product color & flavor may vary due to natural honey
  • TAMPER-EVIDENT FEATURE: Do not use if printed safety seal is torn, broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, elderberry fruit extract, flavor, glycerin, honey, maltodextrin, methylparaben, potassium sorbate, propylparaben, propylene glycol, purified water, sodium chloride, sucralose and zinc sulfate

Questions or comments?

OTC - QUESTIONS SECTION

305-805-3456 Monday - Friday from 9 AM to 5 PM, EST or www.efficientlabs.com

Warnings

WARNINGS SECTION

See the Do not use, Ask a doctor, Ask a doctor or pharmacist, When using, and Keep out of reach of children sections below.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rompe Pechito Allergy for Kids labelRompe Pechito Allergy for Kids labelRompe Pechito Allergy for Kids boxRompe Pechito Allergy for Kids box

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130000856351622GTIN-13: 0000856351622
EAN-13: 0000856351622
GTIN-12: 000856351622
UPC-A: 000856351622
GTIN storage (14 digits): 00000856351622		Rompe_Pechito_Allergy_4oz_BOX.jpg

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
58593-00658593-006-04

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
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
HONEYY9H1V576FHIACT
MALTODEXTRIN7CVR7L4A2DIACT
METHYLPARABENA2I8C7HI9TIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
PROPYLPARABENZ8IX2SC1OHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM CHLORIDE451W47IQ8XIACT
SUCRALOSE96K6UQ3ZD4IACT
ZINC SULFATE89DS0H96TBIACT

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 16 · 309 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nighttime Sleep Aid Berry FlavorDIPHENHYDRAMINE HYDROCHLORIDERaritan Pharmaceuticals Inc303d7651-9c8f-4a14-9f2c-7181fa0f003e2026-09-09WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
VICKS ZzzQuil NIGHTTIME SLEEP-AID Diphenhydramine HCl FREE OFDIPHENHYDRAMINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Company01906eed-78ee-f2a1-e063-6294a90a809b2026-09-08WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
KROGER Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDEKROGER COMPANYa26d63db-8841-47a4-ae09-ac736d7ec3572026-09-02WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
KROGER Dye Free Childrens Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEKROGER COMPANY2bea22e9-34b6-4961-94bb-5600dd90e8912026-09-02WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEKroger514aa6b5-c33b-494c-e063-6294a90a7ace2026-08-27WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEAmazon.com Services LLC298e9164-e378-4b39-a944-bfc8f8baa4de2026-08-27WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
HyVee Maximum Strength Nighttime Sleep-Aid SOFTGELDIPHENHYDRAMINE HYDROCHLORIDEHyVee Inc496ce4ba-08a9-ee99-e063-6294a90ac9a72026-08-21WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst9713d8ee-6ab2-2fdf-e053-2a95a90a9e192026-08-19Warnings, Adverse reactionsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
CVS Health Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy,Inc.a575a914-14a0-442c-a504-ac7a0aa0ac772026-08-18WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
CVS Health Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy,Inc.e8785ba8-e53e-491e-bbfe-04e860f361312026-08-18WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
CVS Health Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy,Inc.9f944edc-a317-4967-ae54-67b5d183591b2026-08-18WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
CVS dye-free childrens allergyDIPHENHYDRAMINE HYDROCHLORIDECVS PHARMACYdb5a5eff-1bb1-4d00-8c01-caae7a1c72232026-08-17WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
SLEEP AIDDIPHENHYDRAMINE HYDROCHLORIDEShield Pharmaceuticals Corp4b6fc81e-e3ba-4a36-834c-82766311aa732026-08-17WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEShield Pharmaceuticals Corp8db277e2-9d98-40b6-8000-a51c57fb4ece2026-08-14WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Nighttime Sleep Aid Berry FlavorDIPHENHYDRAMINE HYDROCHLORIDEWINCO FOODS, LLC6fb6cfde-30a6-419c-973d-8abdc72611ed2026-08-07WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDECardinal Health 107, LLC887cabe5-46d0-4f4e-8f5a-2cfdbc157b582026-08-07WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Winco Foods Childrens Allergy Relief Dye FreeDIPHENHYDRAMINE HYDROCHLORIDEWINCO FOODS, LLCa1367804-37c9-4906-858f-8feeb748d8d32026-08-07WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine HCLDIPHENHYDRAMINE HYDROCHLORIDERedmont Pharmaceuticals, LLCd8944f3c-acef-4ebe-9633-7d641ae95edf2026-08-03Warnings, Adverse reactionsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
DG Health Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEDolgencorp Inced754d5c-74e1-4dee-a5c5-10ccec1b81db2026-08-03WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Good Neighbor Pharmacy allergyDIPHENHYDRAMINE HYDROCHLORIDEAmerisource Bergen9819522f-f3db-4cb8-9680-423114ace2f62026-07-31WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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