Siladryl Allergy Medicine

Manufacturer
Proficient Rx LP
Effective date
2024-01-01
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:12:10

Label at a glance#

ProductSiladryl Allergy Medicine
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure13 sections

Indications and uses

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

Dosage and administration

• repeat dose every 4 to 6 hours • do not take more than 6 doses in any 24-hour period • Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.  adults and children 12 years and over  2 to 4 teaspoonfuls (TSP)  children 6 to under 12 years  1 to 2 teaspoonfuls (TSP)  children under 6 years   DO NOT USE Other information Each 5 mL (1 TSP) contain...

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Diphenhydramine HCl 12.5 mg (in each 5 mL (teaspoonful)(TSP))

OTC - PURPOSE SECTION

Purpose: 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.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

OTC - WHEN USING SECTION

When using this product

  • 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, 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 (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

  • repeat dose every 4 to 6 hours
  • do not take more than 6 doses in any 24-hour period
  • Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

 adults and children 12 years and over

 2 to 4 teaspoonfuls (TSP)

 children 6 to under 12 years

 1 to 2 teaspoonfuls (TSP)

 children under 6 years

 DO NOT USE

Other information
Each 5 mL (1 TSP) contains: Sodium 14 mg. Store at room temperature 20°-25°C (68°-77°F).

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.

SPL UNCLASSIFIED SECTION

Questions

1-844-834-0530

Manufactured by:
Silarx Pharmaceuticals, Inc.
Carmel, NY 10512

Relabeled by:
Proficient Rx LP
Thousand Oaks, CA 91320

10-1043  Rev. 04/18

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Siladryl Allergy 118 mL 10-1043 Rev. 04/18
Siladryl Allergy 118 mL 10-1043 Rev. 04/18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-410-04ML - Milliliter71205-41063533993-ea29-44e0-8373-29e3c24e037812020-04-20
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
71205-41071205-410-04
54838-135

Ingredients#

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

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

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
36009623-fffe-4511-83df-cb513818d0e6c4a35a3e-253a-4815-964a-892d178322522024-01-01WarningsExact identifier
spl id: 36009623-fffe-4511-83df-cb513818d0e6
spl set id: c4a35a3e-253a-4815-964a-892d17832252

Reported adverse events (FAERS/openFDA)#

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