Good Remediestm

Good Remediestm
SPL v2
SPL
SPL Set ID 26a02737-2cfd-769f-e063-6394a90af352
Route
ORAL
Published
Effective Date 2025-01-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Gelatin, Unspecified Glycerin Isopropyl Alcohol Medium-chain Triglycerides Polyethylene Glycol, Unspecified Povidone, Unspecified Water Sorbitol Sorbitan

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-22

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

  • itchy, watery eyes

  • sneezing

  • itching of the nose or throat

• temporarily relieves these symptoms due to the common cold:

  • runny nose

  • sneezing

Section 42229-5

Compare to the active ingredient in Benadryl ® Dye-Free Allergy Liqui-Gels®*

Dye-Free

Relieves:

sneezing, runny nose,

itchy watery eyes, itchy throat

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

Distributed by: Strive Pharmaceuticals Inc.,

East Brunswick, NJ 08816

PRODUCT OF UNITED ARAB EMIRATES

REV.00-112024

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

*This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Benadryl®.

Section 50565-1

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Warnings

Do not use

• to make a child sleepy

• with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

• a breathing problem such as emphysema or chronic bronchitis

• glaucoma

• trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

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.

Packaging

Directions

• take every 4 to 6 hours, or as directed by a doctor

• do not take more than 6 doses in 24 hours

adults and children 12 years and older  1 to 2 softgels
children 6 to under 12 years  1 softgel
children under 6 years  do not use

Other Information

• store at room temperature between 20°-25°C (68°-77°F)

• protect from light, heat and moisture

Inactive Ingredients

edible white ink, gelatin, glycerin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, povidone, purified water, sorbitol sorbitan solution

Questions Or Comments?

1-888-577-8033 Monday-Friday 8am-4pm EST

Active Ingredient (in Each Softgel)

Diphenhydramine HCl 25 mg


Structured Label Content

Uses

• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose

  • itchy, watery eyes

  • sneezing

  • itching of the nose or throat

• temporarily relieves these symptoms due to the common cold:

  • runny nose

  • sneezing

Section 42229-5 (42229-5)

Compare to the active ingredient in Benadryl ® Dye-Free Allergy Liqui-Gels®*

Dye-Free

Relieves:

sneezing, runny nose,

itchy watery eyes, itchy throat

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

Distributed by: Strive Pharmaceuticals Inc.,

East Brunswick, NJ 08816

PRODUCT OF UNITED ARAB EMIRATES

REV.00-112024

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

*This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Benadryl®.

Section 50565-1 (50565-1)

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Purpose

Antihistamine

Warnings

Do not use

• to make a child sleepy

• with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

• a breathing problem such as emphysema or chronic bronchitis

• glaucoma

• trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

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.

Packaging

Directions

• take every 4 to 6 hours, or as directed by a doctor

• do not take more than 6 doses in 24 hours

adults and children 12 years and older  1 to 2 softgels
children 6 to under 12 years  1 softgel
children under 6 years  do not use

Other Information (Other information)

• store at room temperature between 20°-25°C (68°-77°F)

• protect from light, heat and moisture

Inactive Ingredients (Inactive ingredients)

edible white ink, gelatin, glycerin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, povidone, purified water, sorbitol sorbitan solution

Questions Or Comments? (Questions or comments?)

1-888-577-8033 Monday-Friday 8am-4pm EST

Active Ingredient (in Each Softgel) (Active ingredient (in each softgel))

Diphenhydramine HCl 25 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)