good neighbor pharmacy 44-367

good neighbor pharmacy 44-367
SPL v8
SPL
SPL Set ID 147adc14-ca7c-45f5-9925-ea569edbfe96
Route
oral
Published
Effective Date 2025-07-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
diphenhydramine (25 mg)
Inactive Ingredients
starch, corn dibasic calcium phosphate dihydrate fd&c blue no. 1 aluminum lake magnesium stearate microcrystalline cellulose polyethylene glycol, unspecified polyvinyl alcohol, unspecified silicon dioxide stearic acid talc titanium dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 44;367 Shape: oval Color: blue Size: 11 mm Score: 1
Marketing Status
otc monograph drug active Since 2020-07-29

Purpose

Nighttime sleep-aid

Description

Diphenhydramine HCl 25 mg


Medication Information

Uses
  • for relief of occasional sleeplessness

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

Purpose

Nighttime sleep-aid

Directions
  • do not take more than directed

  • adults and children 12 years and over: take 2 caplets at bedtime if needed or as directed by a doctor

  • children under 12 years: do not use

Other Information
  • each caplet contains: calcium 30 mg
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • protect from moisture

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number

Inactive Ingredients

corn starch, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide

Description

Diphenhydramine HCl 25 mg

Principal Display Panel

Good

Neighbor

Pharmacy®

Compare to Simply

Sleep® active ingredient*

  NDC 46122-651-62

Sleep Aid

diphenhydramine HCl 25 mg

nighttime sleep aid

Non-habit forming

• Helps you fall asleep

• Does not contain pain reliever

24 Mini caplets

Actual Size

50844 REV1019A36708

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS

OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR

SHOWS ANY SIGNS OF TAMPERING

Distributed By

AmerisourceBergen

1 West First Avenue

Conshohocken, PA 19428

Questions or Concerns?

www.mygnp.com

*This product is not manufactured or distributed by

Johnson & Johnson Corporation, owner of the

registered trademark Simply Sleep®.

Good Neighbor Pharmacy 44-367
Do Not Use
  • for children under 12 years of age

  • with any other product containing diphenhydramine, even one used on skin
Questions Or Comments?

1-800-426-9391

When Using This Product

avoid alcoholic beverages.

Stop Use and Ask A Doctor If

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Active Ingredient (in Each Caplet)

Diphenhydramine HCl 25 mg

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

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers.


Structured Label Content

Uses
  • for relief of occasional sleeplessness

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

Purpose

Nighttime sleep-aid

Directions
  • do not take more than directed

  • adults and children 12 years and over: take 2 caplets at bedtime if needed or as directed by a doctor

  • children under 12 years: do not use

Other Information (Other information)
  • each caplet contains: calcium 30 mg
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • protect from moisture

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number

Inactive Ingredients (Inactive ingredients)

corn starch, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide

Principal Display Panel (Principal display panel)

Good

Neighbor

Pharmacy®

Compare to Simply

Sleep® active ingredient*

  NDC 46122-651-62

Sleep Aid

diphenhydramine HCl 25 mg

nighttime sleep aid

Non-habit forming

• Helps you fall asleep

• Does not contain pain reliever

24 Mini caplets

Actual Size

50844 REV1019A36708

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS

OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR

SHOWS ANY SIGNS OF TAMPERING

Distributed By

AmerisourceBergen

1 West First Avenue

Conshohocken, PA 19428

Questions or Concerns?

www.mygnp.com

*This product is not manufactured or distributed by

Johnson & Johnson Corporation, owner of the

registered trademark Simply Sleep®.

Good Neighbor Pharmacy 44-367
Do Not Use (Do not use)
  • for children under 12 years of age

  • with any other product containing diphenhydramine, even one used on skin
Questions Or Comments? (Questions or comments?)

1-800-426-9391

When Using This Product (When using this product)

avoid alcoholic beverages.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away.

Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))

Diphenhydramine HCl 25 mg

Ask A Doctor Before Use If You Have (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

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers.


Advanced Ingredient Data


Raw Label Data

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