Only For™

Only For™
SPL v1
SPL
SPL Set ID 5d4b2c79-9580-44a4-9f9f-f9a006d47143
Route
ORAL
Published
Effective Date 2020-11-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2020-11-15

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:

   • 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

ANTIHISTAMINE NIGHTTIME SLEEP-AID

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

Distributed By: O4 GLOBAL TRADING USA, LLC.

12222 Merit Drive, Suite 1900

Dallas, TX 75251-3209

www.onlyfor.com

Packaged By: Strive Pharmaceuticals Inc.

East Brunswick, NJ 08816.

Section 50565-1

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Packaging

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.

Drug Facts

Directions:

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

• do not take more than 6 doses in 24 hours

 adults and children 12 years and over • take 1 to 2 caplets 
 children 6 to under 12 years • take 1 caplet
 children under 6 years • do not use

Other Information:

• store between 20-25°C (68-77°F) excursions permitted between 15-30°C (59-86°F).

• avoid excessive heat and light.

• store in dry place.

Inactive Ingredients:

croscarmellose sodium, dicalcium phosphate, D&C red No.27 aluminium lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide

Questions Or Comments?

1-833-665-9444.

(Mon-Fri 9am - 5pm)

Active Ingredient (in Each Caplet)

Diphenhydramine HCl 25mg


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)

ANTIHISTAMINE NIGHTTIME SLEEP-AID

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

Distributed By: O4 GLOBAL TRADING USA, LLC.

12222 Merit Drive, Suite 1900

Dallas, TX 75251-3209

www.onlyfor.com

Packaged By: Strive Pharmaceuticals Inc.

East Brunswick, NJ 08816.

Section 50565-1 (50565-1)

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Purpose

Antihistamine

Packaging

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.

Drug Facts

Directions:

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

• do not take more than 6 doses in 24 hours

 adults and children 12 years and over • take 1 to 2 caplets 
 children 6 to under 12 years • take 1 caplet
 children under 6 years • do not use

Other Information:

• store between 20-25°C (68-77°F) excursions permitted between 15-30°C (59-86°F).

• avoid excessive heat and light.

• store in dry place.

Inactive Ingredients:

croscarmellose sodium, dicalcium phosphate, D&C red No.27 aluminium lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide

Questions Or Comments? (Questions or comments?)

1-833-665-9444.

(Mon-Fri 9am - 5pm)

Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))

Diphenhydramine HCl 25mg


Advanced Ingredient Data


Raw Label Data

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