Pain Reliever Acetaminophen 325 Mg

Pain Reliever Acetaminophen 325 Mg
SPL v1
SPL
SPL Set ID 3c477d33-a8c2-d39f-e063-6294a90ac5f0
Route
ORAL
Published
Effective Date 2026-01-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg)
Inactive Ingredients
Titanium Dioxide Water Magnesium Stearate Hypromelloses Povidone K30 Talc Polyethylene Glycol 400 Starch, Corn Microcrystalline Cellulose Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: S325 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) Acetaminophen 325 mg

Purpose

Purpose Pain reliever / Fever reducer


Medication Information

Purpose

Purpose

Pain reliever / Fever reducer

Description

Active ingredient (in each caplet) Acetaminophen 325 mg

Uses
  • Temporarily relieves minor aches and pains due to:
  • Headache.
  • Muscular aches.
  • Backache.
  • Minor pain of arthritis.
  • The common 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



Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg) in 24 hours for adults or 5 caplets (1,625 mg) in 24 hours for children. Severe liver damage may occur if:

  • Adult takes more than 4,000 mg of acetaminophen in 24 hours.
  • Child takes more than 5 doses in 24 hours, which is the maximum daily amount.
  • Taken withother drugs containing acetaminophen.
  • Adult has 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 directed (see overdose warning).
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.
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product.

Drug Facts

Active ingredient (in each caplet)

  • Acetaminophen 325 mg
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
  • Store between 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

DR SIMI

NDC 85786-103-90

Regular Strength

Pain Reliever

Acetaminophen 325 mg

Pain Reliever/ Fever Reducer

100 Caplets

Aspirin Free

For Adults

Stop Use and Ask Doctor If
  • Pain gets worse or lasts more than 10 days in adults.
  • Pain gets worse or lasts more than 5 days in children under 12 years.
  • 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 the User Has

liver disease.

Ask A Doctor Or Pharmacist Before Use If the User Is

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 common 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

Purpose

Pain reliever / Fever reducer

Warnings



Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg) in 24 hours for adults or 5 caplets (1,625 mg) in 24 hours for children. Severe liver damage may occur if:

  • Adult takes more than 4,000 mg of acetaminophen in 24 hours.
  • Child takes more than 5 doses in 24 hours, which is the maximum daily amount.
  • Taken withother drugs containing acetaminophen.
  • Adult has 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 directed (see overdose warning).
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.
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product.

Drug Facts

Active ingredient (in each caplet)

  • Acetaminophen 325 mg
Overdose Warning (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).
  • 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 (Principal display panel)

DR SIMI

NDC 85786-103-90

Regular Strength

Pain Reliever

Acetaminophen 325 mg

Pain Reliever/ Fever Reducer

100 Caplets

Aspirin Free

For Adults

Stop Use and Ask Doctor If (Stop use and ask doctor if)
  • Pain gets worse or lasts more than 10 days in adults.
  • Pain gets worse or lasts more than 5 days in children under 12 years.
  • 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 the User Has (Ask a doctor before use if the user has)

liver disease.

Ask A Doctor Or Pharmacist Before Use If the User Is (Ask a doctor or pharmacist before use if the user is)

taking the blood thinning drug warfarin.


Advanced Ingredient Data


Raw Label Data

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