Pain Reliever Pm

Pain Reliever Pm
SPL v4
SPL
SPL Set ID fd7c3250-35d4-494a-e053-6394a90a2db5
Route
ORAL
Published
Effective Date 2024-07-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg) Diphenhydramine (25 mg)
Inactive Ingredients
Silicon Dioxide Fd&c Blue No. 1 Stearic Acid Fd&c Blue No. 2 Polyethylene Glycol 400 Starch, Corn Povidone K30 Croscarmellose Sodium Hypromelloses Polysorbate 80 Cellulose, Microcrystalline Titanium Dioxide Carnauba Wax

Identifiers & Packaging

Pill Appearance
Imprint: G651 Shape: oval Color: blue Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-23

Description

Acetaminophen USP, 500 mg Diphenhydramine HCl USP, 25 mg

Purpose

Pain reliever Nighttime sleep aid


Medication Information

Purpose

Pain reliever Nighttime sleep aid

Description

Acetaminophen USP, 500 mg Diphenhydramine HCl USP, 25 mg

Uses

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

Purposes

Pain reliever

Nighttime sleep aid

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 of this product in 24 hours

children under 12 years

■ 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

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

Overdose Warning

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Other Information

■ store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature.

■ see end panel for lot number and expiration date

Inactive Ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake,

hypromellose, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone k-30, pregelatinized starch, stearic

acid, titanium dioxide

Questions Or Comments?

call 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST

Principal Display Panel

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

Keep Out of Reach of Children

Keep out of reach of children

If Pregnant Or Breast Feeding,

ask a health professional before use

Active Ingredients (in Each Caplet)

Acetaminophen USP, 500 mg

Diphenhydramine HCl USP, 25 mg

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


Structured Label Content

Uses

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

Purposes

Pain reliever

Nighttime sleep aid

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 of this product in 24 hours

children under 12 years

■ do not use

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

Liver Warning (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: (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

Overdose Warning (Overdose warning)

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Other Information (Other information)

■ store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature.

■ see end panel for lot number and expiration date

Inactive Ingredients (Inactive ingredients)

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake,

hypromellose, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone k-30, pregelatinized starch, stearic

acid, titanium dioxide

Questions Or Comments? (Questions or comments?)

call 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST

Principal Display Panel

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

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

Keep out of reach of children

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 USP, 500 mg

Diphenhydramine HCl USP, 25 mg

Ask A Doctor Before Use If You Have (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 (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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