Goodmeds Extra Strength Pain Relief Pm

Goodmeds Extra Strength Pain Relief Pm
SPL v1
SPL
SPL Set ID 02c60967-46d7-49b7-82be-bc3c5fd36484
Route
ORAL
Published
Effective Date 2025-12-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg) Diphenhydramine (25 mg)
Inactive Ingredients
Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Water Stearic Acid Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: S525 Shape: capsule Color: blue Size: 18 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-11

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

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.

Directions
  • do not take more than recommended (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 other products containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
  • with any 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
Drug Facts

Packege Labeling

Other Information

each caplet contains:magnesium 0.05 mg

■ store between 20-25°C (68-77°F)

Inactive Ingredients

FD&C Blue # 1, FD&C Blue # 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, povidone K-30, purified water, stearic acid, titanium dioxide

Questions Or Comments?

contact  1-908-242-6108Mon-Fri 8:00 AM to 5:00 PM EST

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 a serious underlying medical illness
  •  pain gets worse or lasts for 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. 

Keep Out of Reach of Children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. 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.

Ask A Doctor Before Use If You Have
  • liver disease
  • breathing problems such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
  • glaucoma
Active Ingredients (in Each Caplet)

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

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

Purpose

Pain reliever 

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 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.

Directions
  • do not take more than recommended (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 other products containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
  • with any 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
Drug Facts

Packege Labeling

Other Information (Other information)

each caplet contains:magnesium 0.05 mg

■ store between 20-25°C (68-77°F)

Inactive Ingredients (Inactive ingredients)

FD&C Blue # 1, FD&C Blue # 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, povidone K-30, purified water, stearic acid, titanium dioxide

Questions Or Comments? (Questions or comments?)

contact  1-908-242-6108Mon-Fri 8:00 AM to 5:00 PM EST

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 a serious underlying medical illness
  •  pain gets worse or lasts for 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. 

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

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. 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.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • liver disease
  • breathing problems such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
  • glaucoma
Active Ingredients (in Each Caplet) (Active ingredients (in each caplet))

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

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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