Acetaminophen

SPL v3

SPL

SPL Set ID ded10c13-8a4e-469d-8b34-0d6566be016c

Route

ORAL

Published

Effective Date 2019-12-30

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

Drug Facts

Purpose

Pain reliever/fever reducer

Medication Information

Purpose

Pain reliever/fever reducer

Description

Drug Facts

Uses

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

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50568-5

Ask a doctor or pharmacist before use if you aretaking the blood thinning drug warfarin.

Section 50569-3

Ask a doctor before use if you haveliver disease.

Section 53414-9

If pregnant or breast-feeding,ask a health professional before use.

Directions

do not take more than directed (see overdose warning)

adults and children 12 years and over	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
children under 12 years	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?

call 1-800-406-7984

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

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 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

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.

Active Ingredient (in Each Caplet)

Acetaminophen USP, 650 mg

Principal Display Panel 50 Caplet Bottle Carton

NDC 63868-091-50

QUALITY

CHOICE

^†Compare to

Active Ingredient in

TYLENOL ^®8 Hour

Last up to 8 Hours | Use Only as Directed

8 Hour Pain Relief

Acetaminophen Extended-release Tablets USP, 650 mg

Pain Reliever | Fever Reducer

For up to 8 Hours Relief of Minor Muscle Aches & Pain

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

50 CAPLETS* (*capsule-shaped tablets)

Structured Label Content

Uses

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you aretaking the blood thinning drug warfarin.

Section 50569-3 (50569-3)

Ask a doctor before use if you haveliver disease.

Section 53414-9 (53414-9)

If pregnant or breast-feeding,ask a health professional before use.

Purpose

Pain reliever/fever reducer

Directions

do not take more than directed (see overdose warning)

adults and children 12 years and over	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
children under 12 years	do not use

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?

call 1-800-406-7984

Liver Warning (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

Overdose Warning (Overdose warning)

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

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.

Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))

Acetaminophen USP, 650 mg

Principal Display Panel 50 Caplet Bottle Carton (PRINCIPAL DISPLAY PANEL - 50 Caplet Bottle Carton)

NDC 63868-091-50

QUALITY

CHOICE

^†Compare to

Active Ingredient in

TYLENOL ^®8 Hour

Last up to 8 Hours | Use Only as Directed

8 Hour Pain Relief

Acetaminophen Extended-release Tablets USP, 650 mg

Pain Reliever | Fever Reducer

For up to 8 Hours Relief of Minor Muscle Aches & Pain

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

50 CAPLETS* (*capsule-shaped tablets)

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves minor aches and pains due to: muscular aches backache minor pain of arthritis toothache premenstrual and menstrual cramps headache the common cold temporarily reduces fever", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children.", "50568-5": "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.", "50569-3": "Ask a doctor before use if you have liver disease.", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purpose": "Pain reliever/fever reducer", "Directions": "do not take more than directed (see overdose warning ) adults and children 12 years and over 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 children under 12 years 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?": "call 1-800-406-7984", "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", "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 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", "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.", "Active ingredient (in each caplet)": "Acetaminophen USP, 650 mg", "PRINCIPAL DISPLAY PANEL - 50 Caplet Bottle Carton": "NDC 63868-091-50 QUALITY CHOICE † Compare to Active Ingredient in TYLENOL ® 8 Hour Last up to 8 Hours | Use Only as Directed 8 Hour Pain Relief Acetaminophen Extended-release Tablets USP, 650 mg Pain Reliever | Fever Reducer For up to 8 Hours Relief of Minor Muscle Aches & Pain DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN 50 CAPLETS* (*capsule-shaped tablets)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:06.857142 · Updated: 2026-03-14T23:06:27.679265