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

Purpose

Pain reliever Nighttime sleep aid

Description

Acetaminophen 500mg Diphenhydramine HCl 25mg


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

Purpose

Pain reliever

Nighttime sleep aid

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.

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)