Nobleaid

Nobleaid
SPL v1
SPL
SPL Set ID 3f6988df-a596-41f1-b2be-64f8e4b55885
Route
ORAL
Published
Effective Date 2024-08-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-07-01

Description

Diphenhydramine HCl 25mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Diphenhydramine HCl 25mg

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: itchy or watery eyes

   • runny nose itchy nose or throat

   • sneezing

temporarily relieves these symptoms of the common cold:

   • sneezing

   • runny nose

Section 42229-5

Experience fast relief from itchy, puffy, red or watery eyes typically caused by pet dander, hair, pollen, dust and hay fever. You don't have to suffer through allergy symptoms another day longer. Itchy eyes can negatively affect your vision, focus and even work performance.

Diphenhydramine HCL helps reduce and relieve congestion of your nose, sinus and throat to help you breathe better and deeper. The antihistamine effects of this over the counter medication can help reduce the symptoms of the common cold like a runny nose, coughing or sneezing.

Allergy symptoms can make your whole day miserable, but they can also affect your sleep. The antihistamine response may naturally cause drowsiness in both adults and kids, so it is often taken in the evening or before bed to help you fall asleep faster and stay asleep

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Benadryl® Allergy.

Manufactured for

Noble OTC LLC

788 Convery Blvd,

Perth Amboy NJ 08861

www.nobleotc.com

Section 50565-1

In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Warnings

Do not Use:

With any product containing diphenhydramine, even one used on skin

To make a child sleepy

Ask a doctor before use if you have

 trouble urinating due to an enlarged prostate gland

glaucoma

• a breathing problem such as emphysema or chronic bronchi

Ask a doctor or pharmacist before use if you are

taking sedative or tranquilizers

When using this product

marked drowsiness may occur

avoid alcoholic drinks

excitability may occur especially in children

alcohol, sedatives and tranquilizers may increase drowsiness

be careful when driving a motor vehicle or operating machine

If pregnant or breast-feeding, ask a health professional before use.

Packaging

Directions

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

•  24 hours

• adults and children under 12 yrs old and over 1 to 2 caplets children 6 to 12 years of age 1 caplet under children 6 years of age

Other Information

Each caplet contains: Calcium 23.52 mg

Store at controlled room temperature 20-25°C (68-77°F)

Read all the product information before using

TAMPER EVIDENT Do not use if safety seal under cap is broken or missing

Inactive Ingredients

Colloidal silicon dioxide, Croscarmellose sodium, Stearic acid, Talc, Dicalcium phosphate, Polyethylene glycol, Magnesium stearate, Phloxine B Lake, Microcrystalline cellulose, Polyvinyl alcohol, Titanium dioxide

Questions Or Comments?

Please call (347)378-8990 Monday through Friday 9-5 or by Email [email protected]

Active Ingredients (in Each Caplet)

Diphenhydramine HCl 25mg


Structured Label Content

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: itchy or watery eyes

   • runny nose itchy nose or throat

   • sneezing

temporarily relieves these symptoms of the common cold:

   • sneezing

   • runny nose

Section 42229-5 (42229-5)

Experience fast relief from itchy, puffy, red or watery eyes typically caused by pet dander, hair, pollen, dust and hay fever. You don't have to suffer through allergy symptoms another day longer. Itchy eyes can negatively affect your vision, focus and even work performance.

Diphenhydramine HCL helps reduce and relieve congestion of your nose, sinus and throat to help you breathe better and deeper. The antihistamine effects of this over the counter medication can help reduce the symptoms of the common cold like a runny nose, coughing or sneezing.

Allergy symptoms can make your whole day miserable, but they can also affect your sleep. The antihistamine response may naturally cause drowsiness in both adults and kids, so it is often taken in the evening or before bed to help you fall asleep faster and stay asleep

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Benadryl® Allergy.

Manufactured for

Noble OTC LLC

788 Convery Blvd,

Perth Amboy NJ 08861

www.nobleotc.com

Section 50565-1 (50565-1)

In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Purpose

Antihistamine

Warnings

Do not Use:

With any product containing diphenhydramine, even one used on skin

To make a child sleepy

Ask a doctor before use if you have

 trouble urinating due to an enlarged prostate gland

glaucoma

• a breathing problem such as emphysema or chronic bronchi

Ask a doctor or pharmacist before use if you are

taking sedative or tranquilizers

When using this product

marked drowsiness may occur

avoid alcoholic drinks

excitability may occur especially in children

alcohol, sedatives and tranquilizers may increase drowsiness

be careful when driving a motor vehicle or operating machine

If pregnant or breast-feeding, ask a health professional before use.

Packaging

Directions

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

•  24 hours

• adults and children under 12 yrs old and over 1 to 2 caplets children 6 to 12 years of age 1 caplet under children 6 years of age

Other Information (Other information)

Each caplet contains: Calcium 23.52 mg

Store at controlled room temperature 20-25°C (68-77°F)

Read all the product information before using

TAMPER EVIDENT Do not use if safety seal under cap is broken or missing

Inactive Ingredients (Inactive ingredients)

Colloidal silicon dioxide, Croscarmellose sodium, Stearic acid, Talc, Dicalcium phosphate, Polyethylene glycol, Magnesium stearate, Phloxine B Lake, Microcrystalline cellulose, Polyvinyl alcohol, Titanium dioxide

Questions Or Comments? (Questions or Comments?)

Please call (347)378-8990 Monday through Friday 9-5 or by Email [email protected]

Active Ingredients (in Each Caplet) (Active Ingredients (in each caplet))

Diphenhydramine HCl 25mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)