Acetaminophen, Diphenhydramine Hcl Tablets

Acetaminophen, Diphenhydramine Hcl Tablets
SPL v2
SPL
SPL Set ID c1c1de91-6a54-4d91-93a9-b6be6d7c7dfb
Route
ORAL
Published
Effective Date 2018-05-14
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 Fd&c Blue No. 2 Hypromelloses Cellulose, Microcrystalline Povidone Sodium Metabisulfite Stearic Acid Titanium Dioxide Sodium Starch Glycolate Type A Potato Talc Polyethylene Glycol 1000

Identifiers & Packaging

Pill Appearance
Imprint: P525 Shape: capsule Color: blue Size: 18 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-12-05

Description

(in each tablet) Acetaminophen 500mg Diphenhydramine HCl 25mg

Purpose

pain reliever/fever reducer Nighttime sleep aid


Medication Information

Purpose

pain reliever/fever reducer

Nighttime sleep aid

Description

(in each tablet) Acetaminophen 500mg Diphenhydramine HCl 25mg

Uses
  • temporarily relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Warnings

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

  • more than 4000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks everyday while using this product
  • Overdose warning: Taking more than recommended dose (overdose) may cause liver damage. In case of 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.

do not use

  • with any other drug containing acetaminophen (prescription or not prescription). 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
  • With other products containing diphenhydramine, even one used on skin.

ask a doctor before use if you have

  • liver disease
  • asthma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
  • galucoma

ask your doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedative or tranquilizers.

When using this product

  • avoid alcoholic drinks
  • do not drive a motor vehicle or operate machinery, this product will cause drowsiness

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 lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur.
Directions
  • do not exceed recommended dose
  • Adults and children 12 years and over:
  • take 2 caplets at bedtime.
  • do not take more than 2 caplets of this product in 24 hours.

    children under 12 years:

  • do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.
Active Ingredient

(in each tablet)

Acetaminophen 500mg

Diphenhydramine HCl 25mg

Other Information
  • store at 25 °C (77°F) excursions permitted between 15-30°C(59-86°F)
  • do not use if imprinted safety seal under cap is broken or missing

this product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol PM

Inactive Ingredients

Colloidal Silicon Dioxide, Croscarmellose Sodium, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone,  pregelatinized starch, purified water, Sodium metabisulfite, Sodium starch glycolate, stearic acid, Titanium Dioxide, Talc

Questions Or Comments

Call toll free 1-855-314-1850

Keep Out of Reach of Children.

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

Package Label.principal Display Panel

NDC: 76168-119-25   50 COUNT


Structured Label Content

Uses
  • temporarily relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Purpose

pain reliever/fever reducer

Nighttime sleep aid

Warnings

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

  • more than 4000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks everyday while using this product
  • Overdose warning: Taking more than recommended dose (overdose) may cause liver damage. In case of 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.

do not use

  • with any other drug containing acetaminophen (prescription or not prescription). 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
  • With other products containing diphenhydramine, even one used on skin.

ask a doctor before use if you have

  • liver disease
  • asthma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
  • galucoma

ask your doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedative or tranquilizers.

When using this product

  • avoid alcoholic drinks
  • do not drive a motor vehicle or operate machinery, this product will cause drowsiness

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 lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur.
Directions
  • do not exceed recommended dose
  • Adults and children 12 years and over:
  • take 2 caplets at bedtime.
  • do not take more than 2 caplets of this product in 24 hours.

    children under 12 years:

  • do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.
Active Ingredient

(in each tablet)

Acetaminophen 500mg

Diphenhydramine HCl 25mg

Other Information
  • store at 25 °C (77°F) excursions permitted between 15-30°C(59-86°F)
  • do not use if imprinted safety seal under cap is broken or missing

this product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol PM

Inactive Ingredients

Colloidal Silicon Dioxide, Croscarmellose Sodium, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone,  pregelatinized starch, purified water, Sodium metabisulfite, Sodium starch glycolate, stearic acid, Titanium Dioxide, Talc

Questions Or Comments (Questions or Comments)

Call toll free 1-855-314-1850

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

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

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

NDC: 76168-119-25   50 COUNT


Advanced Ingredient Data


Raw Label Data

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