Allergy Relief Antihistamine

Allergy Relief Antihistamine
SPL v4
SPL
SPL Set ID c5fdd413-912f-4f80-8376-2dd6c4eabbde
Route
ORAL
Published
Effective Date 2022-09-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Gelatin, Unspecified Glycerin Polyethylene Glycol, Unspecified Povidone, Unspecified Water Sorbitol Sorbitan

Identifiers & Packaging

Pill Appearance
Imprint: 783 Shape: capsule Color: white Size: 15 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-05-01

Description

Drug Facts

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Drug Facts

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 34088-5

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.

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children

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:

• 
glaucoma    •  trouble urinating due to an enlarged prostate gland    •  a breathing problem such as emphysema or chronic bronchitis

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 • do not take more than 6 doses in 24 hours.

adults and children 12 years of age and over   1 to 2 softgel
children 6 to under 12 years   1 softgel
children under 6 years of age   do not use this product

Other Information

• store at room temperature between 20-25°C (68-77°F)   • avoid excessive heat, humidity and light

Inactive Ingredients

edible white ink, gelatin, glycerin, polyethylene glycol, povidone, purified water, sorbitol sorbitan solution

Questions Or Comments?

Call: 1-888-577-8033 Monday - Friday 9am-4:30pm EST

Active Ingredient (in Each Softgel)

Diphenhydramine HCl 25mg


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 34088-5 (34088-5)

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.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children

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:

• 
glaucoma    •  trouble urinating due to an enlarged prostate gland    •  a breathing problem such as emphysema or chronic bronchitis

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 • do not take more than 6 doses in 24 hours.

adults and children 12 years of age and over   1 to 2 softgel
children 6 to under 12 years   1 softgel
children under 6 years of age   do not use this product

Other Information (Other information)

• store at room temperature between 20-25°C (68-77°F)   • avoid excessive heat, humidity and light

Inactive Ingredients (Inactive ingredients)

edible white ink, gelatin, glycerin, polyethylene glycol, povidone, purified water, sorbitol sorbitan solution

Questions Or Comments? (Questions or Comments?)

Call: 1-888-577-8033 Monday - Friday 9am-4:30pm EST

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

Diphenhydramine HCl 25mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)