Right Remedies

Right Remedies
SPL v2
SPL
SPL Set ID b4fc014c-7c5f-46a4-bf13-57103b6fa018
Route
ORAL
Published
Effective Date 2021-12-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Butylparaben D&c Red No. 28 Fd&c Blue No. 1 Fd&c Red No. 40 Gelatin, Unspecified Lactose Monohydrate Magnesium Stearate Methylparaben Polysorbate 80 Propylparaben Water Sodium Lauryl Sulfate Starch, Corn

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-12-20

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 the active ingredient of Benadryl®Allergy *

• Sneezing

• Runny nose

• Itchy, watery eyes

• Itchy throat

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

*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Benadryl® Allergy

Distributed by:

Strive Pharmaceuticals Inc.

East Brunswick, NJ 08816

Product of India

Packaged and Quality Assured in the USA

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 older                          1 to 2 capsules
 children 6 to under 12 years                                 1 capsule
 children under 6 years old                               do not use

Other Information

• store between 20-25°C (68-77°F) • protect from light.

Inactive Ingredients

butylparaben, D&C red #28, edible ink, FD&C blue #1, FD&C red #40, gelatin, lactose monohydrate, magnesium stearate, methylparaben, polysorbate-80, propylparaben, purified water, sodium lauryl sulphate, starch

Questions Or Comments?

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

Active Ingredient (in Each Capsule)

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 the active ingredient of Benadryl®Allergy *

• Sneezing

• Runny nose

• Itchy, watery eyes

• Itchy throat

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

*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Benadryl® Allergy

Distributed by:

Strive Pharmaceuticals Inc.

East Brunswick, NJ 08816

Product of India

Packaged and Quality Assured in the USA

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 older                          1 to 2 capsules
 children 6 to under 12 years                                 1 capsule
 children under 6 years old                               do not use

Other Information (Other information)

• store between 20-25°C (68-77°F) • protect from light.

Inactive Ingredients (Inactive ingredients)

butylparaben, D&C red #28, edible ink, FD&C blue #1, FD&C red #40, gelatin, lactose monohydrate, magnesium stearate, methylparaben, polysorbate-80, propylparaben, purified water, sodium lauryl sulphate, starch

Questions Or Comments? (Questions or comments?)

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

Active Ingredient (in Each Capsule) (Active ingredient (in each capsule))

Diphenhydramine HCl 25 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)