Allergy Relief Caplet

Allergy Relief Caplet
SPL v5
SPL
SPL Set ID 126c05e7-2cd9-47d3-96c3-82305714e1db
Route
ORAL
Published
Effective Date 2025-01-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Croscarmellose Sodium Dibasic Calcium Phosphate Dihydrate D&c Red No. 27 Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Silicon Dioxide Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: S2 Shape: oval Color: pink Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-05-01

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, watery eyes  • itching of the nose or throat 

• 
temporarily relieves these symptoms due to the common cold:

  • runny nose • sneezing

Section 42229-5

COMPARE TO BENADRYL® ALLERGY ULTRATAB® ACTIVE INGREDIENT*

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

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

*This product is not manufactured or distributed by Johnson & Johnson Consumer Inc. owner of the registered trademark Benadryl® Allergy ULTRATAB®.

DISTRIBUTED BY

TOPCO ASSOCIATES LLC

ITASCA, IL 60143

©TOPCO STVA1023

[email protected]

www.topcarebrand.com

PRODUCT OF INDIA

QUALITY GUARANTEED

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. 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 drinks

• alcohol, sedatives, and tranquilizers may increase drowsiness

• be careful 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 times in 24 hours

 adults and children 12 years and over  1 to 2 tablets
 children 6 to under 12 years  1 tablet
 children under 6 years  do not use

Drug Facts

Other Information

•  store between 20-25°C (68-77°F)

• avoid excessive heat, cold and humidity

• close cap tightly after use

Inactive Ingredients

croscarmellose sodium, dicalcium phosphate DT, D&C red #27, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide

Questions Or Comments:

Call 1-888-423-0139

Active Ingredient (in Each Tablet)

Diphenhydramine HCl 25 mg


Structured Label Content

Uses

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

  •
runny nose  • sneezing  • itchy, watery eyes  • 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 BENADRYL® ALLERGY ULTRATAB® ACTIVE INGREDIENT*

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

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

*This product is not manufactured or distributed by Johnson & Johnson Consumer Inc. owner of the registered trademark Benadryl® Allergy ULTRATAB®.

DISTRIBUTED BY

TOPCO ASSOCIATES LLC

ITASCA, IL 60143

©TOPCO STVA1023

[email protected]

www.topcarebrand.com

PRODUCT OF INDIA

QUALITY GUARANTEED

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. 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 drinks

• alcohol, sedatives, and tranquilizers may increase drowsiness

• be careful 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 times in 24 hours

 adults and children 12 years and over  1 to 2 tablets
 children 6 to under 12 years  1 tablet
 children under 6 years  do not use

Drug Facts

Other Information (Other information)

•  store between 20-25°C (68-77°F)

• avoid excessive heat, cold and humidity

• close cap tightly after use

Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, dicalcium phosphate DT, D&C red #27, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide

Questions Or Comments: (Questions or comments:)

Call 1-888-423-0139

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Diphenhydramine HCl 25 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)