kroger diphenhydramine hydrochloride 25 mg softgels

kroger diphenhydramine hydrochloride 25 mg softgels
SPL v2
SPL
SPL Set ID 0fec16a4-b4eb-8f8f-e063-6394a90a7327
Route
oral
Published
Effective Date 2023-12-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
diphenhydramine (25 mg)
Inactive Ingredients
propylene glycol polyethylene glycol 400 shellac water titanium dioxide fd&c red no. 40 gelatin sorbitol solution fd&c blue no. 1 sorbitan

Identifiers & Packaging

Pill Appearance
Imprint: 121 Shape: capsule Color: purple Size: 16 mm Score: 1
Marketing Status
otc monograph drug active Since 2024-04-15
Purpose

Nighttime sleep-aid

Description

Diphenhydramine HCl 25 mg

Medication Information

Warnings

Do not use

■ for children under 12 years of age

■ with any other product containing diphenhydramine, even one used on skin.

Uses

■ for the relief of occasional sleeplessness

■ reduces time to fall asleep if you have difficulty falling asleep

Purpose

Nighttime sleep-aid

Directions

■ take only one dose per day (24 hours)



adults & children 12 yrs & over

2 softgels at bedtime if needed or as directed by a doctor
children under 12 yrs do not use

Other Information

■ store at 20-25° C (68-77°F)

■ avoid excessive heat above 40°C (104°F)

■ protect from light

Inactive Ingredients

FD&C blue no. 1, FD&C red no. 40, gelatin, polyethylene glycol 400, propylene glycol, purified water, shellac,sorbitol sorbitan solution, titanium dioxide.

Description

Diphenhydramine HCl 25 mg

Section 50565-1

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9

Stop use and ask a doctor ifsleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

Section 50567-7

When using this product

■ avoid alcoholic beverages

Section 50568-5

Ask a doctor or pharmacist before use if you aretaking sedatives or tranquilizers

Section 50569-3

Ask a doctor before use if you have

■ a breathing problem such as emphysema or chronic bronchitis

■ glaucoma

■ difficulty in urination due to enlargement of the prostate gland

Section 50570-1

Do not use

■ for children under 12 years of age

■ with any other product containing diphenhydramine, even one used on skin.

Section 51945-4

Section 53413-1

Questions or comments? Call 1-800-632-6900

Section 53414-9

If pregnant or breast-feeding,ask a health professional before use.

Active Ingredient (in Each Softgel)

Diphenhydramine HCl 25 mg

Structured Label Content

Warnings

Do not use

■ for children under 12 years of age

■ with any other product containing diphenhydramine, even one used on skin.

Uses

■ for the relief of occasional sleeplessness

■ reduces time to fall asleep if you have difficulty falling asleep

Purpose

Nighttime sleep-aid

Directions

■ take only one dose per day (24 hours)



adults & children 12 yrs & over

2 softgels at bedtime if needed or as directed by a doctor
children under 12 yrs do not use

Other Information (Other information)

■ store at 20-25° C (68-77°F)

■ avoid excessive heat above 40°C (104°F)

■ protect from light

Inactive Ingredients (Inactive ingredients)

FD&C blue no. 1, FD&C red no. 40, gelatin, polyethylene glycol 400, propylene glycol, purified water, shellac,sorbitol sorbitan solution, titanium dioxide.

Section 50565-1 (50565-1)

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor ifsleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

Section 50567-7 (50567-7)

When using this product

■ avoid alcoholic beverages

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you aretaking sedatives or tranquilizers

Section 50569-3 (50569-3)

Ask a doctor before use if you have

■ a breathing problem such as emphysema or chronic bronchitis

■ glaucoma

■ difficulty in urination due to enlargement of the prostate gland

Section 50570-1 (50570-1)

Do not use

■ for children under 12 years of age

■ with any other product containing diphenhydramine, even one used on skin.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments? Call 1-800-632-6900

Section 53414-9 (53414-9)

If pregnant or breast-feeding,ask a health professional before use.

Active Ingredient (in Each Softgel) (Active ingredient (in each softgel))

Diphenhydramine HCl 25 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:58.208192 · Updated: 2026-03-14T23:02:48.423363