Acetaminophen

Acetaminophen
SPL v3
SPL
SPL Set ID 6f880abe-5284-42b0-9db6-b071444b197b
Route
ORAL
Published
Effective Date 2019-08-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (650 mg)
Inactive Ingredients
Croscarmellose Sodium Gelatin, Unspecified Glycerin Hypromellose, Unspecified Ferrosoferric Oxide Ferric Oxide Yellow Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Povidone, Unspecified Starch, Corn Propylene Glycol Sodium Lauryl Sulfate Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 350 Shape: round Color: white Size: 13 mm Score: 1
Marketing Status
ANDA Active Since 2012-12-21
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:
    • minor pain of arthritis
    • muscular aches
    • backache
    • premenstrual and menstrual cramps
    • the common cold
    • headache
    • toothache
  • 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
adults
  • take 2 geltabs every 8 hours. Swallow only one geltab at a time.
  • take a sip of water before swallowing each geltab and wash each geltab down with water (up to a full 8 oz. glass).
  • swallow whole; do not crush, chew, split or dissolve
  • do not take more than 6 geltabs 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 have difficulty swallowing large tablets or capsules. People over 65 may have difficulty swallowing these tablets.
  • 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 geltabs 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 high humidity.
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.
Inactive Ingredients

croscarmellose sodium, gelatin, glycerin, hypromellose, iron oxide black, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, sodium lauryl sulfate, starch (corn), 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
  • the tablet got stuck in your throat

These could be signs of a serious condition.

Active Ingredient (in Each Geltab)

Acetaminophen USP, 650 mg

Principal Display Panel 650 Mg Tablet Bottle Label

CVS

HEALTH ™

Compare to the active ingredient

in Tylenol ®8HR Arthritis Pain*

Geltabs†

8HR Arthritis

Pain Relief

ACETAMINOPHEN

EXTENDED-RELEASE TABLETS, USP 650 mg

DO NOT USE WITH OTHER

MEDICINES CONTAINING

ACETAMINOPHEN

THIS PACKAGE IS FOR

HOUSEHOLDS WITHOUT

YOUNG CHILDREN

Pain reliever; Fever reducer

  • For the temporary relief

    of minor arthritis pain
  • Lasts up to 8 hours

Use only as directed.

80 GELTABS†

†GELATIN-COATED TABLETS

Actual Size

Structured Label Content

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
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
adults
  • take 2 geltabs every 8 hours. Swallow only one geltab at a time.
  • take a sip of water before swallowing each geltab and wash each geltab down with water (up to a full 8 oz. glass).
  • swallow whole; do not crush, chew, split or dissolve
  • do not take more than 6 geltabs 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 have difficulty swallowing large tablets or capsules. People over 65 may have difficulty swallowing these tablets.
  • 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 geltabs 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)

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 at 20 - 25° C (68 - 77° F). Avoid high humidity.
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.
Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, gelatin, glycerin, hypromellose, iron oxide black, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, sodium lauryl sulfate, starch (corn), 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
  • the tablet got stuck in your throat

These could be signs of a serious condition.

Active Ingredient (in Each Geltab) (Active ingredient (in each geltab))

Acetaminophen USP, 650 mg

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

CVS

HEALTH ™

Compare to the active ingredient

in Tylenol ®8HR Arthritis Pain*

Geltabs†

8HR Arthritis

Pain Relief

ACETAMINOPHEN

EXTENDED-RELEASE TABLETS, USP 650 mg

DO NOT USE WITH OTHER

MEDICINES CONTAINING

ACETAMINOPHEN

THIS PACKAGE IS FOR

HOUSEHOLDS WITHOUT

YOUNG CHILDREN

Pain reliever; Fever reducer

  • For the temporary relief

    of minor arthritis pain
  • Lasts up to 8 hours

Use only as directed.

80 GELTABS†

†GELATIN-COATED TABLETS

Actual Size

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:05.378814 · Updated: 2026-03-14T23:06:23.767952