Pain Relief 100 Acetaminophen 500

Pain Relief 100 Acetaminophen 500
SPL v1
SPL
SPL Set ID 3c42e48d-cdb2-eb74-e063-6394a90a2940
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)
Inactive Ingredients
Talc Starch, Corn Titanium Dioxide Water Stearic Acid Povidone K30 Magnesium Stearate Microcrystalline Cellulose Hypromelloses Polyethylene Glycol 400

Identifiers & Packaging

Pill Appearance
Imprint: S500 Shape: capsule Color: white Size: 17 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-13

Description

Active ingredient (in each caplet) Purpose Acetaminophen 500 mg Pain reliever / Fever reducer

Purpose

Active ingredient (in each caplet) Purpose Acetaminophen 500 mg Pain reliever/Fever reducer


Medication Information

Purpose
Active ingredient (in each caplet) Purpose

Acetaminophen 500 mg

Pain reliever/Fever reducer

Description

Active ingredient (in each caplet) Purpose Acetaminophen 500 mg Pain reliever / Fever reducer

Uses
  • Temporarily relieves minor aches and pains due to:
  • Headache
  • Muscular aches
  • Backache
  • Minor pain of arthritis
  • The comon cold
  • Toothache
  • Premenstrual and menstrual cramps
  • Temporarily reduces fever.
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

Warnings

Warnings

Directions
  • Do not take 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.
  • If you are allergic to acetaminophen or any of the inactive ingredients in this product
Drug Facts
Active ingredient (in each caplet) Purpose
Acetaminophen 500 mg Pain reliever / Fever reducer

Overdose Warning

In case of overdose, get medical help or contact a Poison Control Center righ 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 at controlled room temperature 20-25°C (68-77°F)
  • Read all product information before using
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Inactive Ingredients

Hypromellose, Magnesium stearate, Microcrystalline cellulose, Polyethylene glycol 400, Povidone, Pregelatinized starch, Purified water, Stearic acid, Talc, Titanium dioxide.

Questions Or Comments?

(855)-280-1079

Principal Display Panel

NDC 85786-102-90

Extra Strenght

Pain Reliever

Acetaminophen 500 mg

Pain Reliever/Fever Reducer

100 Caplets

Aspirin Free

For Aduls

Stop Use and Ask A Doctor If
  • Pain gets worse or lasts more than 10 days.
  • Fever gets worse or lasts more than 3 days.
  • New symptoms occur.
  • Redness or swelling is present.

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

lliver disease

Ask Your Doctor Or Pharmacist Before Use If You Are
  • Taking the blood thinning drug warfarin

Structured Label Content

Uses
  • Temporarily relieves minor aches and pains due to:
  • Headache
  • Muscular aches
  • Backache
  • Minor pain of arthritis
  • The comon cold
  • Toothache
  • Premenstrual and menstrual cramps
  • Temporarily reduces fever.
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

Purpose
Active ingredient (in each caplet) Purpose

Acetaminophen 500 mg

Pain reliever/Fever reducer

Warnings

Warnings

Directions
  • Do not take 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.
  • If you are allergic to acetaminophen or any of the inactive ingredients in this product
Drug Facts
Active ingredient (in each caplet) Purpose
Acetaminophen 500 mg Pain reliever / Fever reducer

Overdose Warning (Overdose warning)

In case of overdose, get medical help or contact a Poison Control Center righ 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 at controlled room temperature 20-25°C (68-77°F)
  • Read all product information before using
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Inactive Ingredients (Inactive ingredients)

Hypromellose, Magnesium stearate, Microcrystalline cellulose, Polyethylene glycol 400, Povidone, Pregelatinized starch, Purified water, Stearic acid, Talc, Titanium dioxide.

Questions Or Comments? (Questions or comments?)

(855)-280-1079

Principal Display Panel

NDC 85786-102-90

Extra Strenght

Pain Reliever

Acetaminophen 500 mg

Pain Reliever/Fever Reducer

100 Caplets

Aspirin Free

For Aduls

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • Pain gets worse or lasts more than 10 days.
  • Fever gets worse or lasts more than 3 days.
  • New symptoms occur.
  • Redness or swelling is present.

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)

lliver disease

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

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)