Acetaminophen And Diphenhydramine Citrate

SPL v4

SPL

SPL Set ID 403a88fa-e06b-9b6e-e063-6394a90a97b8

Route

ORAL

Published

Effective Date 2024-01-30

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (500 mg) Diphenhydramine (38 mg)

Inactive Ingredients

Hypromelloses Magnesium Stearate Titanium Dioxide Polyethylene Glycol 400 Fd&c Blue No. 2 Fd&c Blue No. 1 Cellulose, Microcrystalline Starch, Corn Povidone K30 Silicon Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: S26 Shape: capsule Color: blue Size: 18 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-10-01

Description

KEEP OUT OF THE REACH OF CHILDREN

Medication Information

Warnings and Precautions

KEEP OUT OF THE REACH OF CHILDREN,REMOVE SILICA GEL BAG BEFORE USE

Indications and Usage

Analgesic and Antipyretic

Dosage and Administration

FOR MANUFACTURING, PROCESSING OR REPACKING

Description

KEEP OUT OF THE REACH OF CHILDREN

Section 50565-1

KEEP OUT OF THE REACH OF CHILDREN

Section 51727-6

Microcrystalline Cellulose, Polyethylene glycol, Polyvinyl pyrrolidinone, Pregelatinized Starch, Starch, Stearic Acid powder, colloidal Silicon Dioxide, talc, Hypromellose

Section 55105-1

FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING

Principal Display Panel

Structured Label Content

Indications and Usage (34067-9)

Analgesic and Antipyretic

Dosage and Administration (34068-7)

FOR MANUFACTURING, PROCESSING OR REPACKING

Warnings and Precautions (34071-1)

KEEP OUT OF THE REACH OF CHILDREN,REMOVE SILICA GEL BAG BEFORE USE

Section 50565-1 (50565-1)

KEEP OUT OF THE REACH OF CHILDREN

Section 51727-6 (51727-6)

Microcrystalline Cellulose, Polyethylene glycol, Polyvinyl pyrrolidinone, Pregelatinized Starch, Starch, Stearic Acid powder, colloidal Silicon Dioxide, talc, Hypromellose

Section 55105-1 (55105-1)

FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34067-9": "Analgesic and Antipyretic ", "34068-7": "FOR MANUFACTURING, PROCESSING OR REPACKING", "34071-1": "KEEP OUT OF THE REACH OF CHILDREN,REMOVE SILICA GEL BAG BEFORE USE", "50565-1": "KEEP OUT OF THE REACH OF CHILDREN", "51727-6": "Microcrystalline Cellulose, Polyethylene glycol, Polyvinyl pyrrolidinone, Pregelatinized Starch, Starch, Stearic Acid powder, colloidal Silicon Dioxide, talc, Hypromellose", "55105-1": "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:07:09.279333 · Updated: 2026-03-14T23:10:23.192014