Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (650 mg)

Inactive Ingredients

Croscarmellose Sodium Magnesium Stearate Propylene Glycol Sodium Lauryl Sulfate Stearic Acid Titanium Dioxide Hypromellose, Unspecified Microcrystalline Cellulose Povidone, Unspecified Starch, Corn

Identifiers & Packaging

Pill Appearance

Imprint: cor116 Shape: oval Color: white Size: 19 mm Score: 1

Marketing Status

ANDA Active Since 2004-04-30

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
- •
  premenstrual and menstrual cramps
- •
  the common cold
- •
  headache
- •
  toothache
•
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

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)

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).
•
see end panel for batch number and expiration date
•
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

Principal Display Panel

fred's ^®

Use only as directed.

LAST UP TO 8 HOURS

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

50 CAPLETS^* (^*capsule-shaped tablets)

Compare To Active Ingredient of Tylenol ^® Arthritis Pain ^†

DISTRIBUTED BY: fred's, Inc.

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.

Structured Label Content

Uses (USES)

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

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 (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).
•
see end panel for batch number and expiration date
•
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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

fred's ^®

Use only as directed.

LAST UP TO 8 HOURS

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

50 CAPLETS^* (^*capsule-shaped tablets)

Compare To Active Ingredient of Tylenol ^® Arthritis Pain ^†

DISTRIBUTED BY: fred's, Inc.

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.

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"USES": "• temporarily relieves minor aches and pains due to: • minor pain of arthritis • muscular aches • backache • premenstrual and menstrual cramps • the common cold • headache • toothache • temporarily reduces fever", "PURPOSE": "Pain reliever/fever reducer", "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 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) 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). • see end panel for batch number and expiration date • 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", "PRINCIPAL DISPLAY PANEL": "fred's ® Use only as directed. LAST UP TO 8 HOURS 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 50 CAPLETS * ( * capsule-shaped tablets) Compare To Active Ingredient of Tylenol ® Arthritis Pain † DISTRIBUTED BY: fred's, Inc.", "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."}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information