Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 71be6a5b-aff2-4757-804a-085b44e2a7d3
Route
ORAL
Published
Effective Date 2019-04-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (650 mg)
Inactive Ingredients
Croscarmellose Sodium Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Povidone, Unspecified Starch, Corn Propylene Glycol Sodium Lauryl Sulfate Stearic Acid Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: cor116 Shape: oval Color: white Size: 19 mm Score: 1
Marketing Status
ANDA Active Since 2002-04-30

Description

Acetaminophen USP, 650 mg

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen USP, 650 mg

Uses
  • temporarily relieves minor aches and pains due to:
    • minor pain of arthritis
    • muscular aches
    • backache
    • headache
    • toothache
    • the common cold
    • premenstrual and menstrual cramps
  • temporarily reduces fever
Warnings

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

  • more than 6 caplets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product
Directions
  • do not take more than directed (see overdose warning)
    adults ▪ take 2 caplets every 8 hours with water

    ▪ swallow whole - do not crush, chew, split or dissolve

    ▪ do not take more than 6 caplets in 24 hours

    ▪ do not use for more than 10 days unless directed by a doctor
    under 18 years of age ▪ ask a doctor
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.
Questions?

Call 1-800-406-7984

Other Information
  • store at 20 - 25° C (68 - 77° F). Avoid excessive heat 40° C (104° F).
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.
Inactive Ingredients

Croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, sodium lauryl sulfate, stearic acid, titanium dioxide

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.

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.

Active Ingredient (in Each Caplet)

Acetaminophen USP, 650 mg

Ask A Doctor Before Use If You Have

Liver disease.

Ask A Doctor Or Pharmacist Before Use If You Are

Taking the blood thinning drug warfarin.

Principal Display Panel 650 Mg Caplet Bottle Label

Compare to the active ingredient

in Tylenol® Arthritis Pain

GOOD

NEIGHBOR

PHARMACY®

NDC 46122-170-81

Last up to 8 HOURS

Use only as directed.

Arthritis Pain Relief

acetaminophen

extended-release tablets

USP, 650 mg

Pain Reliever/Fever Reducer

For the Temporary Relief of Minor Arthritis Pain

DO NOT USE WITH OTHER MEDICINES

CONTAINING ACETAMINOPHEN

200 caplets*

(*capsule-shaped tablets)


Structured Label Content

Uses (USES)
  • temporarily relieves minor aches and pains due to:
    • minor pain of arthritis
    • muscular aches
    • backache
    • headache
    • toothache
    • the common cold
    • premenstrual and menstrual cramps
  • temporarily reduces fever
Purpose (PURPOSE)

Pain reliever/fever reducer

Warnings (WARNINGS)

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

  • more than 6 caplets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product
Directions (DIRECTIONS)
  • do not take more than directed (see overdose warning)
    adults ▪ take 2 caplets every 8 hours with water

    ▪ swallow whole - do not crush, chew, split or dissolve

    ▪ do not take more than 6 caplets in 24 hours

    ▪ do not use for more than 10 days unless directed by a doctor
    under 18 years of age ▪ ask a doctor
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.
Questions? (QUESTIONS?)

Call 1-800-406-7984

Other Information (OTHER INFORMATION)
  • store at 20 - 25° C (68 - 77° F). Avoid excessive heat 40° C (104° F).
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.
Inactive Ingredients (INACTIVE INGREDIENTS)

Croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, sodium lauryl sulfate, stearic acid, titanium dioxide

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.)

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.

Active Ingredient (in Each Caplet) (ACTIVE INGREDIENT (IN EACH CAPLET))

Acetaminophen USP, 650 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

Liver disease.

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.

Principal Display Panel 650 Mg Caplet Bottle Label (PRINCIPAL DISPLAY PANEL - 650 mg Caplet Bottle Label)

Compare to the active ingredient

in Tylenol® Arthritis Pain

GOOD

NEIGHBOR

PHARMACY®

NDC 46122-170-81

Last up to 8 HOURS

Use only as directed.

Arthritis Pain Relief

acetaminophen

extended-release tablets

USP, 650 mg

Pain Reliever/Fever Reducer

For the Temporary Relief of Minor Arthritis Pain

DO NOT USE WITH OTHER MEDICINES

CONTAINING ACETAMINOPHEN

200 caplets*

(*capsule-shaped tablets)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)