Equate 44-190

Equate 44-190
SPL v17
SPL
SPL Set ID c88e93d4-66b6-4327-b9e5-0e0a95a18d66
Route
ORAL
Published
Effective Date 2025-06-07
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 1990-03-15

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
    • sneezing
    • itchy, water eyes
    • itching of the nose or throat
  • temporarily relieves these symptoms due to the common cold:
    • runny nose
    • sneezing
Directions
  • take every 4 to 6 hours
  • do not take more than 6 doses 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 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • 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?

1-888-287-1915

Principal Display Panel

equate™

NDC 49035-901-08

Compare

to Benadryl®

Active

Ingredient*

Allergy Relief

Diphenhydramine HCl, 25 mg

Antihistamine

Relieves:

• Sneezing

• Itchy, watery eyes

• Runny nose

• Itchy throat

Each capsule individually

banded for your protection

25

mg

EACH

24

CAPSULES

Actual size

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

Satisfaction guaranteed - Or

we'll replace it or give you your

money back. For questions or

comments or to report an

undesired reaction or side effect,

please call 1-888-287-1915.

DISTRIBUTED BY: Walmart Inc.,

Bentonville, AR 72716



*This product is not manufactured or distributed by

Johnson & Johnson Corporation, owner of the registered

trademark Benadryl®.

50844                                                     REV1117H19008

Equate 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
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • 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
    • sneezing
    • itchy, water eyes
    • itching of the nose or throat
  • temporarily relieves these symptoms due to the common cold:
    • runny nose
    • sneezing
Purpose

Antihistamine

Directions
  • take every 4 to 6 hours
  • do not take more than 6 doses 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 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • 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?)

1-888-287-1915

Principal Display Panel

equate™

NDC 49035-901-08

Compare

to Benadryl®

Active

Ingredient*

Allergy Relief

Diphenhydramine HCl, 25 mg

Antihistamine

Relieves:

• Sneezing

• Itchy, watery eyes

• Runny nose

• Itchy throat

Each capsule individually

banded for your protection

25

mg

EACH

24

CAPSULES

Actual size

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

Satisfaction guaranteed - Or

we'll replace it or give you your

money back. For questions or

comments or to report an

undesired reaction or side effect,

please call 1-888-287-1915.

DISTRIBUTED BY: Walmart Inc.,

Bentonville, AR 72716



*This product is not manufactured or distributed by

Johnson & Johnson Corporation, owner of the registered

trademark Benadryl®.

50844                                                     REV1117H19008

Equate 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)
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • 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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