3d55914e-0769-2282-e063-6394a90a3a48

SPL v4
SPL
SPL Set ID 3d55914e-0769-2282-e063-6394a90a3a48
Route
oral
Published
Effective Date 2026-01-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging

Description

diphenydramine HCL 25mg 

Medication Information

Warnings and Precautions

for further packing and labelling 

Active Ingredient

diphenydramine HCL 25mg 

Indications and Usage

antihstaminc and for further final packing 

Dosage and Administration

antihsitaminc and for further packing 

Description

diphenydramine HCL 25mg 

Section 50565-1

keep out of reach children 

Section 51727-6

Allura Red AC IH, Brilliant blue FCF IH, Gelatin 160 BLOOM USP/NF, Glycerin USP, Polyethylene Glycol 400 - India glycols USP/NF,,Purified water, Sorbitol solution 70% Non crystalline,Medium chain triglycerides,white ink.

Section 51945-4

bulk label

Section 55105-1

antihistaminc and for further packing and labelling 

Structured Label Content

Warnings and Precautions (34071-1)

for further packing and labelling 

Active Ingredient (55106-9)

diphenydramine HCL 25mg 

Indications and Usage (34067-9)

antihstaminc and for further final packing 

Dosage and Administration (34068-7)

antihsitaminc and for further packing 

Section 50565-1 (50565-1)

keep out of reach children 

Section 51727-6 (51727-6)

Allura Red AC IH, Brilliant blue FCF IH, Gelatin 160 BLOOM USP/NF, Glycerin USP, Polyethylene Glycol 400 - India glycols USP/NF,,Purified water, Sorbitol solution 70% Non crystalline,Medium chain triglycerides,white ink.

Section 51945-4 (51945-4)

bulk label

Section 55105-1 (55105-1)

antihistaminc and for further packing and labelling 

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:20.335341 · Updated: 2026-02-15T12:08:20.296372