Only For™

Only For™
SPL v1
SPL
SPL Set ID ff61406a-ca7c-4b8d-a730-8bdbceab0389
Route
ORAL
Published
Effective Date 2020-12-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg) Diphenhydramine (25 mg)
Inactive Ingredients
Silicon Dioxide Croscarmellose Sodium Fd&c Blue No. 1 Hypromellose, Unspecified Magnesium Stearate Starch, Corn Microcrystalline Cellulose Polyethylene Glycol 400 Povidone, Unspecified Talc Titanium Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-11-15

Description

Acetaminophen 500mg Diphenhydramine HCl 25mg

Purpose

Pain reliever Nighttime sleep aid


Medication Information

Purpose

Pain reliever

Nighttime sleep aid

Description

Acetaminophen 500mg Diphenhydramine HCl 25mg

Uses:

• temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

Section 42229-5

ADULT

PAIN RELIEVER 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.

OVERDOSE WARNINGS:  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.

Packaging

Warnings:

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

• more than 4,000 mg of acetaminophen in 24 hours

• with other drugs containing acetaminophen

• 3 or more alcoholic drinks every day while using this product

Allergy Alert:

Acetaminophen may cause severe skin reactions.

Symptoms may include:

• skin reddening

• blisters

• rash

If a skin reaction occurs, stop use and seek medical help right away.

Do not use

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

• with any other product containing diphenhydramine, even one used on skin

• in children under 12 years of age

• if you have ever had an allergic reaction to this product or any of its ingredients.

Ask a doctor before use if you have

liver disease

a breathing problem such as emphysema or chronic bronchitis

trouble urinating due to an enlarged prostate gland

glaucoma.

Ask a doctor or pharmacist before use if

• you are taking the blood thinning drug warfarin

• taking sedatives or tranquilizers.

When using this product

• drowsiness will occur

• avoid alcoholic drinks

• do not drive a motor vehicle or operate machinery.

Stop use and ask a doctor if

• sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness

• pain gets worse or lasts more than 10 days

• fever gets worse or last more than 3 days

• redness or swelling is present

• new symptoms occur.

These could be signs of a serious condition.

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

Drug Facts

Directions:

take with a full glass of water

Do not take more than directed. SEE OVERDOSE WARNING.

do not take more than 2 caplets in 24 hours

adults and children 12 years of age and over

 • take 2 caplets at bedtime

 • do not take more than 2 caplets of this product in 24 hours

 children under 12 years of age  • do not use

Other Information:

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

avoid excessive heat, cold and humidity.

close cap tightly after use.

Inactive Ingredients:

colloidal silicon dioxide, croscarmellose sodium, FD&C blue No.1, hydroxy propyl methyl cellulose, magnesium stearate, starch, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide.

Questions Or Comments?

1-833-665-9444. (Mon-Fri 9am-5pm)

Active Ingredient (in Each Caplet)

Acetaminophen 500mg

Diphenhydramine HCl 25mg


Structured Label Content

Uses:

• temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

Section 42229-5 (42229-5)

ADULT

PAIN RELIEVER 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.

OVERDOSE WARNINGS:  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

Pain reliever

Nighttime sleep aid

Packaging

Warnings:

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

• more than 4,000 mg of acetaminophen in 24 hours

• with other drugs containing acetaminophen

• 3 or more alcoholic drinks every day while using this product

Allergy Alert:

Acetaminophen may cause severe skin reactions.

Symptoms may include:

• skin reddening

• blisters

• rash

If a skin reaction occurs, stop use and seek medical help right away.

Do not use

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

• with any other product containing diphenhydramine, even one used on skin

• in children under 12 years of age

• if you have ever had an allergic reaction to this product or any of its ingredients.

Ask a doctor before use if you have

liver disease

a breathing problem such as emphysema or chronic bronchitis

trouble urinating due to an enlarged prostate gland

glaucoma.

Ask a doctor or pharmacist before use if

• you are taking the blood thinning drug warfarin

• taking sedatives or tranquilizers.

When using this product

• drowsiness will occur

• avoid alcoholic drinks

• do not drive a motor vehicle or operate machinery.

Stop use and ask a doctor if

• sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness

• pain gets worse or lasts more than 10 days

• fever gets worse or last more than 3 days

• redness or swelling is present

• new symptoms occur.

These could be signs of a serious condition.

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

Drug Facts

Directions:

take with a full glass of water

Do not take more than directed. SEE OVERDOSE WARNING.

do not take more than 2 caplets in 24 hours

adults and children 12 years of age and over

 • take 2 caplets at bedtime

 • do not take more than 2 caplets of this product in 24 hours

 children under 12 years of age  • do not use

Other Information:

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

avoid excessive heat, cold and humidity.

close cap tightly after use.

Inactive Ingredients:

colloidal silicon dioxide, croscarmellose sodium, FD&C blue No.1, hydroxy propyl methyl cellulose, magnesium stearate, starch, microcrystalline cellulose, polyethylene glycol, povidone, 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))

Acetaminophen 500mg

Diphenhydramine HCl 25mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)