FDA.reportPublic FDA data

Siladryl Allergy Medicine

Manufacturer
American Health Packaging
Effective date
2023-06-09
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:30:13

Label at a glance#

ProductSiladryl Allergy Medicine
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure15 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 right dose on chart below take every 4 to 6 hours do not take more than 6 doses in any 24-hour period adults and children 12 years and over 1 cup (10 mL) to 2 cups (20 mL) children 6 to under 12 years 1/2 cup (5 mL) to 1 cup (10 mL) children under 6 years DO NOT USE

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each 10 mL cup)
Diphenhydramine HCl 25 mg

Purpose

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

Warnings

WARNINGS SECTION

Do not use

  • to 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 an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • a sodium restricted diet

Ask a doctor or pharmacist before use

OTC - ASK DOCTOR/PHARMACIST SECTION

if you are taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

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

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • find right dose on chart below
  • take every 4 to 6 hours
  • do not take more than 6 doses in any 24-hour period

adults and children 12 years and over

1 cup (10 mL) to 2 cups (20 mL)

children 6 to under 12 years

1/2 cup (5 mL) to 1 cup (10 mL)

children under 6 years

DO NOT USE

Other information

SPL UNCLASSIFIED SECTION

  • Each 10 mL cup contains: Sodium 28 mg.
  • Store between 20° to 25°C (68° to 77°F).
  • Protect from light.
  • DO NOT USE IF SEAL IS BROKEN.
  • This drug product is supplied in 10 mL unit dose cups as:
    30 cups (3 x 10) NDC 60687-267-08
    100 cups (10 x 10) NDC 60687-267-56

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, D&C red no. 33, FD&C red no. 40, black cherry flavor, methylparaben, propylene glycol, propylparaben, saccharin sodium, sodium citrate, sorbitol, water.

PACKAGING INFORMATION

SPL UNCLASSIFIED SECTION

American Health Packaging unit dose cups contain drug product Siladryl Allergy (Diphenhydramine Hydrochloride) from Silarx Pharmaceuticals, Inc. as follows:
(25 mg per 10 mL / 30 UD) NDC 60687-267-08packaged from NDC 54838-135
(25 mg per 10 mL / 100 UD) NDC 60687-267-56 packaged from NDC 54838-135

Distributed by:
American Health Packaging
Columbus, OH 43217

8426769/1121F

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Diphenhydramine Hydrochloride Tray LabelDiphenhydramine Hydrochloride Tray Label

Diphenhydramine
Hydrochloride
Liquid
Antihistamine

•Sugar Free • Alcohol Free

FOR INSTITUTIONAL USE ONLY

Store between
20° and 25°C (68° and 77°F).
Protect from light.

8426769/1121F

Principal Display Panel – Cup - 25 mg per 10 mL/10 mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

25 mg per 10 mL Diphenhydramine Hydrochloride Liquid Cup Label25 mg per 10 mL Diphenhydramine Hydrochloride Liquid Cup Label

NDC 60687- 267-42

Diphenhydramine
Hydrochloride Liquid
Antihistamine

25 mg / 10 mL
Delivers 10 mL

Sugar Free. Alcohol Free.

See package Drug Facts insert for
information and storage.

For Institutional Use Only.

American Health Packaging
Columbus, OH 43217

0426769/0221

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-267-08ML - Milliliter60687-2671a482c02-230b-4fb3-a0df-185106052d1912022-04-06
60687-267-42ML - Milliliter60687-26781c98df9-9364-4a3a-b364-9d15361bc20812020-07-13
60687-267-48ML - Milliliter60687-2674bb048ee-6144-4fbe-b0da-db0a9a09558712020-08-06
60687-267-56ML - Milliliter60687-267d5b8e2b9-558b-4417-a369-f12d60cecaab12020-07-13
54838-135-40ML - Milliliter54838-13587d16fcc-e01c-4b61-ae11-a13ea6bb905612012-07-24
54838-135-70ML - Milliliter54838-135f13f7b19-421d-47eb-a27f-5cdbb6c15d2612012-07-24
54838-135-80ML - Milliliter54838-1354a60ef46-6956-40fc-bc99-ce529980ed8c12012-07-24

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60687-26760687-267-42, 60687-267-48, 60687-267-56, 60687-267-08
54838-135

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
D&C RED NO. 339DBA0SBB0LIACT
FD&C RED NO. 40WZB9127XOAIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT
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
fdb74c89-255b-ab2b-e053-6294a90a098bfc58008e-c2ab-4070-ab14-a17f26829b952023-06-09WarningsExact identifier
spl id: fdb74c89-255b-ab2b-e053-6294a90a098b
spl set id: fc58008e-c2ab-4070-ab14-a17f26829b95

Reported adverse events (FAERS/openFDA)#

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