Goodsense 44-190

Goodsense 44-190
SPL v7
SPL
SPL Set ID fac64ddc-a89b-4d73-b9e5-edc4e5cc3c4b
Route
ORAL
Published
Effective Date 2025-06-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Butylparaben Starch, Corn D&c Red No. 28 Fd&c Blue No. 1 Fd&c Red No. 40 Gelatin, Unspecified Anhydrous Lactose Magnesium Stearate Methylparaben Polysorbate 80 Propylparaben Silicon Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 44;107 Shape: capsule Color: pink Color: white Size: 14 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-06-02

Description

Diphenhydramine HCl 25 mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Diphenhydramine HCl 25 mg

Uses
  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • itching of the nose or throat
    • itchy, watery eyes
    • sneezing
  • temporarily relieves these symptoms due to the common cold:
    • runny nose
    • sneezing
Directions
  • do not take more than directed
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 times in 24 hours
adults and children 12 years and over

1 to 2 capsules

children 6 to under 12 years

1 capsule

children under 6 years

do not use
Do Not Use
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin 
Other Information
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN OR IF RED BAND AROUND CAPSULE IS BROKEN OR MISSING
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • protect from moisture
  • see end flap for expiration date and lot number
Inactive Ingredients

butylparaben, corn starch, D&C red #28, edible ink, FD&C blue #1, FD&C red #40, gelatin, lactose anhydrous, magnesium stearate, methylparaben, polysorbate 80, propylparaben, silicon dioxide

Questions Or Comments?

1-800-426-9391

Principal Display Panel

GOODSENSE®

NDC 50804-091-08

Allergy Relief

Diphenhydramine HCI, 25 mg

Antihistamine

Sneezing,

Itchy, Watery Eyes

Runny Nose,

Itchy Throat

*Compare to the active ingredient of

Benadryl® Allergy

actual size

24 Capsules

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED

OR IF BLISTER UNIT IS TORN OR BROKEN OR IF

RED BAND AROUND CAPSULE IS BROKEN OR MISSING

*This product is not manufactured or distributed by Kenvue

Inc., owner of the registered trademark Benadryl® Allergy.

50844           REV0524C19008

Distributed by: Perrigo Direct, Inc.

Peachtree City, GA 30269

www.PerrigoDirect.com (1-800-426-9391)

GoodSense® is a registered trademark of

L. Perrigo Company.

Good Sense 44-190
When Using This Product
  • marked drowsiness may occur
  • avoid alcoholic beverages

  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • use caution when driving a motor vehicle or operating machinery

  • excitability may occur, especially in children 
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.

Ask A Doctor Before Use If You Have
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urination due to enlargement of the prostate gland

Active Ingredient (in Each Banded Capsule)

Diphenhydramine HCl 25 mg

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers.


Structured Label Content

Uses
  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • itching of the nose or throat
    • itchy, watery eyes
    • sneezing
  • temporarily relieves these symptoms due to the common cold:
    • runny nose
    • sneezing
Purpose

Antihistamine

Directions
  • do not take more than directed
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 times in 24 hours
adults and children 12 years and over

1 to 2 capsules

children 6 to under 12 years

1 capsule

children under 6 years

do not use
Do Not Use (Do not use)
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin 
Other Information (Other information)
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN OR IF RED BAND AROUND CAPSULE IS BROKEN OR MISSING
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • protect from moisture
  • see end flap for expiration date and lot number
Inactive Ingredients (Inactive ingredients)

butylparaben, corn starch, D&C red #28, edible ink, FD&C blue #1, FD&C red #40, gelatin, lactose anhydrous, magnesium stearate, methylparaben, polysorbate 80, propylparaben, silicon dioxide

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel

GOODSENSE®

NDC 50804-091-08

Allergy Relief

Diphenhydramine HCI, 25 mg

Antihistamine

Sneezing,

Itchy, Watery Eyes

Runny Nose,

Itchy Throat

*Compare to the active ingredient of

Benadryl® Allergy

actual size

24 Capsules

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED

OR IF BLISTER UNIT IS TORN OR BROKEN OR IF

RED BAND AROUND CAPSULE IS BROKEN OR MISSING

*This product is not manufactured or distributed by Kenvue

Inc., owner of the registered trademark Benadryl® Allergy.

50844           REV0524C19008

Distributed by: Perrigo Direct, Inc.

Peachtree City, GA 30269

www.PerrigoDirect.com (1-800-426-9391)

GoodSense® is a registered trademark of

L. Perrigo Company.

Good Sense 44-190
When Using This Product (When using this product)
  • marked drowsiness may occur
  • avoid alcoholic beverages

  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • use caution when driving a motor vehicle or operating machinery

  • excitability may occur, especially in children 
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.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urination due to enlargement of the prostate gland

Active Ingredient (in Each Banded Capsule) (Active ingredient (in each banded capsule))

Diphenhydramine HCl 25 mg

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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