Whole Foods-diphenhydramine Hydrochloride Capsules, 25 Mg-dye Free

Whole Foods-diphenhydramine Hydrochloride Capsules, 25 Mg-dye Free
SPL v2
SPL
SPL Set ID 32352109-31dc-8e6f-e063-6294a90a2f92
Route
ORAL
Published
Effective Date 2025-04-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Sorbitan Gelatin Polyethylene Glycol 400 Water Glycerin Propylene Glycol Sorbitol

Identifiers & Packaging

Pill Appearance
Imprint: DF25 Shape: capsule Color: white Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-27

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 the other upper respiratory allergies:

■ runny nose ■ sneezing ■ itching of the nose or throat ■ itchy, watery eyes

Section 42229-5

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP JS BROKEN OR MISSING

KEEP THIS CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

DISTRIBUTED BY: WHOLE FOODS MARKET | 550 BOWIE STREET, AUSTIN, TX 78703 | ©2020 WHOLE FOODS MARKET IP, INC | www.wholefoodsmarket.com

PRODUCT OF INDIA| ** THIS PRODUCT IS NOT MANUFACTURED OR DISTRIBUTED BY THE OWNERS OF BENADRYL ®ALLERGY LIQUI-GELS ®

Mfg.Lic. No. : TN00002123

2122772

L0000952

R0125

Warnings

■ May cause excitability especially in children.

■ May cause marked drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect.

30's Count

NDC 42681-0050-1

365

WHOLE FOODS MARKET

Antihistamine

Allergy Relief

Diphenhydramine HCl

Capsules USP, 25 mg

Sneezing | Runny nose

Itchy, Watery Eyes | Itchy Throat or Nose

** Compare to the Active Ingridient in

Benadryl ®Allergy LIQUI-GELS ®

30

SOFTGELS*

*liquid-filled capsules

Directions

■ Do not use for children under 6 years of age ■ 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 this product for children under 6 years of age

Do Not Use

■ Do not use for children under 6 years of age ■ with any other product containing diphenhydramine, even one used on skin.

Other Information

■ store at 20°C to 25°C (68°F to 77°F)

■ avoid high humidity and excessive heat above 40°C (104°F).

■ protect from light

Inactive Ingredients

gelatin, glycerin, polyethylene glycol 400, propylene glycol, purified water, sorbitol sorbitan solution

Questions Or Comments?

call toll-free 1-888-235-2466(Mon - Fri 9AM - 5PM EST)

When Using This Product

■ avoid alcoholic beverages ■ be careful when driving a motor vehicle or operating machinery

Stop Use and Ask A Doctor If

sleeplessness persists continuously for more than 2 weeks

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 Capsule)

Diphenhydramine HCl 25 mg

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

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 the other upper respiratory allergies:

■ runny nose ■ sneezing ■ itching of the nose or throat ■ itchy, watery eyes

Section 42229-5 (42229-5)

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP JS BROKEN OR MISSING

KEEP THIS CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

DISTRIBUTED BY: WHOLE FOODS MARKET | 550 BOWIE STREET, AUSTIN, TX 78703 | ©2020 WHOLE FOODS MARKET IP, INC | www.wholefoodsmarket.com

PRODUCT OF INDIA| ** THIS PRODUCT IS NOT MANUFACTURED OR DISTRIBUTED BY THE OWNERS OF BENADRYL ®ALLERGY LIQUI-GELS ®

Mfg.Lic. No. : TN00002123

2122772

L0000952

R0125

Purpose

Antihistamine

Warnings

■ May cause excitability especially in children.

■ May cause marked drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect.

30's Count (30's count)

NDC 42681-0050-1

365

WHOLE FOODS MARKET

Antihistamine

Allergy Relief

Diphenhydramine HCl

Capsules USP, 25 mg

Sneezing | Runny nose

Itchy, Watery Eyes | Itchy Throat or Nose

** Compare to the Active Ingridient in

Benadryl ®Allergy LIQUI-GELS ®

30

SOFTGELS*

*liquid-filled capsules

Directions

■ Do not use for children under 6 years of age ■ 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 this product for children under 6 years of age

Do Not Use (Do not use)

■ Do not use for children under 6 years of age ■ with any other product containing diphenhydramine, even one used on skin.

Other Information (Other information)

■ store at 20°C to 25°C (68°F to 77°F)

■ avoid high humidity and excessive heat above 40°C (104°F).

■ protect from light

Inactive Ingredients (Inactive ingredients)

gelatin, glycerin, polyethylene glycol 400, propylene glycol, purified water, sorbitol sorbitan solution

Questions Or Comments? (Questions or comments?)

call toll-free 1-888-235-2466(Mon - Fri 9AM - 5PM EST)

When Using This Product (When using this product)

■ avoid alcoholic beverages ■ be careful when driving a motor vehicle or operating machinery

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

sleeplessness persists continuously for more than 2 weeks

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 Capsule) (Active ingredient (in each capsule))

Diphenhydramine HCl 25 mg

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

Ask A Doctor Or Pharmacist Before Use (Ask a doctor or pharmacist before use)

if you are taking sedatives or tranquilizers.


Advanced Ingredient Data


Raw Label Data

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