Pain Relief Pm

Pain Relief Pm
SPL v3
SPL
SPL Set ID 32a5611b-9bf6-4850-a7ff-fa240da04f45
Route
ORAL
Published
Effective Date 2024-09-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg) Acetaminophen (500 mg)
Inactive Ingredients
Fd&c Blue No. 1 Fd&c Blue No. 2 Hypromellose, Unspecified Microcrystalline Cellulose Magnesium Stearate Polyethylene Glycol 400 Starch, Corn Povidone, Unspecified Stearic Acid Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: None Shape: capsule Color: blue Size: 27 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-30

Description

Acetaminophen 500 mg Diphenhydramine 25 mg

Purpose

Acetaminophen 500 mg ....................................................................................................................................Pain reliever Diphenhydramine HCl 25 mg ...........................................................................….................................Nighttime sleep aid


Medication Information

Purpose

Acetaminophen 500 mg ....................................................................................................................................Pain reliever

Diphenhydramine HCl 25 mg ...........................................................................….................................Nighttime sleep aid

Description

Acetaminophen 500 mg Diphenhydramine 25 mg

Uses:
  • temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Section 50565-1

KEEP OUT OF REACH OF CHILDREN

Overdose warning: In case of overdose, get medical help or contact Poison Control (1-800-222-1222) right away.

Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 51945-4

Warnings:

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take ■ more than 4,000 mg of acetaminophen in 24 hrs ■ 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.

Directions:

■ do not take more than directed (see overdose warning) adults and children 12 years and over

■ take 2 caplets at bedtime

■ do not take more than 2 caplets in 24 hours unless directed by a doctor

■ children under 12 years do not use

Other Information:
  • store at 20°-25°C (68°-77°F)

Inactive Ingredients:

FD & C Blue # 1, FD & C Blue # 2, Hypromellose, Microcrystalline Cellulose, Magnesium Stearate, Polyethylene glycol 400, Pregelatinized Starch, Polyvinyl Pyrrolidone, Stearic Acid Powder, Titanium Dioxide.

Questions Or Comments?

Call 1-718-337-8733 or visit [email protected]

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 lasts 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.

Active Ingredients (in Each Caplet)

Acetaminophen 500 mg

Diphenhydramine 25 mg

Ask A Doctor Before Use If You Have:

■ liver disease

■ glaucoma

■ a breathing problem such as emphysema or chronic bronchitis

■ trouble urinating due to an enlarged prostate gland.

Ask A Doctor Or Pharmacist Before Use If You Are 
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

Structured Label Content

Uses:
  • temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN

Overdose warning: In case of overdose, get medical help or contact Poison Control (1-800-222-1222) right away.

Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 51945-4 (51945-4)

Purpose

Acetaminophen 500 mg ....................................................................................................................................Pain reliever

Diphenhydramine HCl 25 mg ...........................................................................….................................Nighttime sleep aid

Warnings:

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take ■ more than 4,000 mg of acetaminophen in 24 hrs ■ 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 (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.

Directions:

■ do not take more than directed (see overdose warning) adults and children 12 years and over

■ take 2 caplets at bedtime

■ do not take more than 2 caplets in 24 hours unless directed by a doctor

■ children under 12 years do not use

Other Information:
  • store at 20°-25°C (68°-77°F)

Inactive Ingredients:

FD & C Blue # 1, FD & C Blue # 2, Hypromellose, Microcrystalline Cellulose, Magnesium Stearate, Polyethylene glycol 400, Pregelatinized Starch, Polyvinyl Pyrrolidone, Stearic Acid Powder, Titanium Dioxide.

Questions Or Comments? (Questions or Comments?)

Call 1-718-337-8733 or visit [email protected]

When Using This Product (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 (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. These could be signs of a serious condition.

If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

ask a health professional before use.

Active Ingredients (in Each Caplet) (Active Ingredients (in each caplet))

Acetaminophen 500 mg

Diphenhydramine 25 mg

Ask A Doctor Before Use If You Have: (Ask a doctor before use if you have:)

■ liver disease

■ glaucoma

■ a breathing problem such as emphysema or chronic bronchitis

■ trouble urinating due to an enlarged prostate gland.

Ask A Doctor Or Pharmacist Before Use If You Are  (Ask a doctor or pharmacist before use if you are )
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

Advanced Ingredient Data


Raw Label Data

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