Dollar General 44-672

Dollar General 44-672
SPL v4
SPL
SPL Set ID 9f1e2e1f-d3e8-4c8a-9e3e-c2ab9e4c79e8
Route
ORAL
Published
Effective Date 2025-06-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Starch, Corn D&c Red No. 27 Aluminum Lake Dibasic Calcium Phosphate Dihydrate Fd&c Blue No. 2 Aluminum Lake Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Silicon Dioxide Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 44;672 Shape: oval Color: purple Size: 14 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-06-30

Description

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid


Medication Information

Purpose

Nighttime sleep-aid

Description

Diphenhydramine HCl 25 mg

Uses
  • for relief of occasional sleeplessness
  • reduces time to fall asleep if you have difficulty falling asleep
Directions
  • do not take more than directed
  • adults and children 12 years and over: take 2 caplets (50 mg) at bedtime if needed, or as directed by a doctor
  • children under 12 years: do not use
Do Not Use
  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
Other Information
  • each caplet contains: calcium 65 mg
  • avoid excessive heat (greater than 100ºF) or humidity
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • use by expiration date on package
Inactive Ingredients

corn starch, D&C red #27 aluminum lake, dibasic calcium phosphate dihydrate, FD&C blue #2 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide

Questions Or Comments?

1-888-309-9030

Principal Display Panel

DG™  | health

Compare to

active ingredient of

VICKS® ZzzQuil®

Nighttime Sleep-Aid*

Night Time

Sleep Aid

Diphenhydramine HCl, 25 mg

Nighttime Sleep-Aid

Non-Habit Forming

Not for Pain

Not for Colds

365 Caplets

Actual Caplet Size

25

mg each

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL

UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by The Procter & Gamble

Company, owner of the registered trademark VICKS® ZzzQuil® Nighttime

Sleep-Aid.             

50844        ORG041967251

DISTRIBUTED BY

OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

100%

Satisfaction

Guaranteed!


(888) 309-9030

Dollar General 44-672
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 (50 mg) at bedtime if needed, or as directed by a doctor
  • children under 12 years: do not use
Do Not Use (Do not use)
  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
Other Information (Other information)
  • each caplet contains: calcium 65 mg
  • avoid excessive heat (greater than 100ºF) or humidity
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • use by expiration date on package
Inactive Ingredients (Inactive ingredients)

corn starch, D&C red #27 aluminum lake, dibasic calcium phosphate dihydrate, FD&C blue #2 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide

Questions Or Comments? (Questions or comments?)

1-888-309-9030

Principal Display Panel (Principal display panel)

DG™  | health

Compare to

active ingredient of

VICKS® ZzzQuil®

Nighttime Sleep-Aid*

Night Time

Sleep Aid

Diphenhydramine HCl, 25 mg

Nighttime Sleep-Aid

Non-Habit Forming

Not for Pain

Not for Colds

365 Caplets

Actual Caplet Size

25

mg each

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL

UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by The Procter & Gamble

Company, owner of the registered trademark VICKS® ZzzQuil® Nighttime

Sleep-Aid.             

50844        ORG041967251

DISTRIBUTED BY

OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

100%

Satisfaction

Guaranteed!


(888) 309-9030

Dollar General 44-672
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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