Extra Strength Pain Reliever Pm

Extra Strength Pain Reliever Pm
SPL v1
SPL
SPL Set ID 3c19ad99-6e0f-3116-e063-6394a90a914c
Route
ORAL
Published
Effective Date 2025-12-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg) Diphenhydramine (25 mg)
Inactive Ingredients
Fd&c Blue No. 1 Starch, Corn Water Fd&c Blue No. 2 Stearic Acid Hypromellose, Unspecified Microcrystalline Cellulose Polyethylene Glycol, Unspecified Magnesium Stearate Povidone K30 Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: APM Shape: oval Color: blue Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-11

Description

Active ingredients (in each caplet) Acetaminophen 500 mg Diphenhydramine HCl 25 mg


Medication Information

Warnings and Precautions

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

  • More than 2 caplets in 24 hours, which is the maximum daily amount for this product.
  • With other drugs containing acetaminophen.
  • 3 or more alcoholicdrinks 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.

Description

Active ingredients (in each caplet) Acetaminophen 500 mg Diphenhydramine HCl 25 mg

Uses

Temporarily relief of occasional headaches and minor aches and pains with accompanying sleeplessness.

Pupose
  • Pain reliever
  • Nighttime sleep aid
Section 42229-5

Distributed by: FARMACIAS DE SIMILARES TX, LLC

800 Brazos St Ste 260, Austin, TX,

78701, USA.

[email protected]

www.drsimi.com

LOT:

EXP:

PEEL BACK for more DRUG FACTS

Section 51945-4

DR SIMI

NDC 85786-101-90

Extra Strength

Pain Reliver PM

Acetaminophen 500 mg

Pain Reliever

Diphenhydramine HCl 25 mg

Nightime Sleep Aid

100 Caplets

Aspirin Free

Non-Habit Forming

For Adults

Warnings

Warnings

Directions
  • ​Do not use more than directed (see overdose warning).
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.
  • If you have ever had an allergic reaction to this product or any of its ingredients.
Drug Facts

Active ingredients (in each caplet)

  • Acetaminophen 500 mg
  • Diphenhydramine HCl 25 mg

Other Information
  • Store at 25 °C (77°F) excursions permitted between 15-30°C (59-86°F)
  • Read all product information before using.
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

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.

Inactive Ingredients

FD&C Blue No. 1, FD&C Blue No. 2, Hypromellose, Magnesium stearate, Microcrystalline cellulose, Polyethylene glycol, Povidone, Pregelatinized starch, Purified water, Stearic Acid, Titanium dioxide.

Questions Or Comments?

(855)-280-1079

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.

Keep Out of Reach of Children.

Keep out of reach of children.

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 Your Doctor Or Pharmacist Before Use If You Are
  • Taking the blood thinning drug warfarin
  • Taking sedative or tranquilizers.

Structured Label Content

Uses

Temporarily relief of occasional headaches and minor aches and pains with accompanying sleeplessness.

Pupose
  • Pain reliever
  • Nighttime sleep aid
Warnings and Precautions (34071-1)

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

  • More than 2 caplets in 24 hours, which is the maximum daily amount for this product.
  • With other drugs containing acetaminophen.
  • 3 or more alcoholicdrinks 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.

Section 42229-5 (42229-5)

Distributed by: FARMACIAS DE SIMILARES TX, LLC

800 Brazos St Ste 260, Austin, TX,

78701, USA.

[email protected]

www.drsimi.com

LOT:

EXP:

PEEL BACK for more DRUG FACTS

Section 51945-4 (51945-4)

DR SIMI

NDC 85786-101-90

Extra Strength

Pain Reliver PM

Acetaminophen 500 mg

Pain Reliever

Diphenhydramine HCl 25 mg

Nightime Sleep Aid

100 Caplets

Aspirin Free

Non-Habit Forming

For Adults

Warnings

Warnings

Directions
  • ​Do not use more than directed (see overdose warning).
Do Not Use (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.
  • If you have ever had an allergic reaction to this product or any of its ingredients.
Drug Facts

Active ingredients (in each caplet)

  • Acetaminophen 500 mg
  • Diphenhydramine HCl 25 mg

Other Information (Other information)
  • Store at 25 °C (77°F) excursions permitted between 15-30°C (59-86°F)
  • Read all product information before using.
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

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.

Inactive Ingredients (Inactive ingredients)

FD&C Blue No. 1, FD&C Blue No. 2, Hypromellose, Magnesium stearate, Microcrystalline cellulose, Polyethylene glycol, Povidone, Pregelatinized starch, Purified water, Stearic Acid, Titanium dioxide.

Questions Or Comments? (Questions or comments?)

(855)-280-1079

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.

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

Keep out of reach of children.

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 Your Doctor Or Pharmacist Before Use If You Are (Ask your doctor or pharmacist before use if you are)
  • Taking the blood thinning drug warfarin
  • Taking sedative or tranquilizers.

Advanced Ingredient Data


Raw Label Data

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