Only For

Only For
SPL v1
SPL
SPL Set ID bf363466-0b1b-48e3-b00b-51077286a3ec
Route
ORAL
Published
Effective Date 2019-04-30
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--aluminum Lake Hypromellose 2910 (5 Mpa.s) Magnesium Palmitostearate Starch, Corn Microcrystalline Cellulose 101 Polyethylene Glycol 400 Povidone, Unspecified Talc Titanium Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2019-03-29

Description

Acetaminophen 500 mg Diphenhydramine HCl 25 mg

Purpose

Pain reliever Nighttime sleep aid


Medication Information

Purpose

Pain reliever

Nighttime sleep aid

Description

Acetaminophen 500 mg Diphenhydramine HCl 25 mg

Uses:
  • temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Section 42229-5

NDC: 73006-119-41

Distributed By: O4 GLOBAL TRADING USA LLC., 2241 S Watson RD, Suite 121 Arlington, TX 76010.

www.onlyfor.com

Packaged By: Strive Pharmaceuticals Inc., East Brunswick, NJ 08816.

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF A BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGN OF TAMPERING.

Tear along perforation push product through foil

Packaging

Warnings:

Liver warning:

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

  • more than 1,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks everyday 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 any allergic reaction to this product or any of its ingredients
  • for more than 10 days for pain unless directed by a doctor
  • for more than 3 days for fever unless directed by a doctor

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 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 continously 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
  •  2 caplets at bedtime
  • do not take more than 2 caplets 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).
Inactive Ingredients:

Colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1, hydroxypropyl methyl cellulose, magnesium stearate, maize starch, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide.

Questions Or Comments ?

1-833-665-9444.

Keep Out of Reach of Children

Overdose Warning: 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.

Active Ingredient (in Each Caplet)

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg


Structured Label Content

Uses:
  • temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Section 42229-5 (42229-5)

NDC: 73006-119-41

Distributed By: O4 GLOBAL TRADING USA LLC., 2241 S Watson RD, Suite 121 Arlington, TX 76010.

www.onlyfor.com

Packaged By: Strive Pharmaceuticals Inc., East Brunswick, NJ 08816.

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF A BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGN OF TAMPERING.

Tear along perforation push product through foil

Purpose

Pain reliever

Nighttime sleep aid

Packaging

Warnings:

Liver warning:

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

  • more than 1,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks everyday 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 any allergic reaction to this product or any of its ingredients
  • for more than 10 days for pain unless directed by a doctor
  • for more than 3 days for fever unless directed by a doctor

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 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 continously 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 (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
  •  2 caplets at bedtime
  • do not take more than 2 caplets 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).
Inactive Ingredients:

Colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1, hydroxypropyl methyl cellulose, magnesium stearate, maize starch, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide.

Questions Or Comments ?

1-833-665-9444.

Keep Out of Reach of Children (Keep out of reach of children)

Overdose Warning: 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.

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

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg


Advanced Ingredient Data


Raw Label Data

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