Mckesson Pain Reliever Drug Facts

Mckesson Pain Reliever Drug Facts
SPL v2
SPL
SPL Set ID 0a7d82f8-7615-4cef-b245-94b186f3c8fa
Route
RECTAL
Published
Effective Date 2025-04-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (120 mg)
Inactive Ingredients
Cottonseed Oil

Identifiers & Packaging

Marketing Status
ANDA Active Since 2025-04-07
Description

Acetaminophen 120 mg

Purpose

Pain reliever/fever reducer

Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 120 mg

Uses

temporarily

  • •
    reduces fever
  • •
    relieves minor aches, pains, and headache
Purposes

Pain reliever/fever reducer

Warnings

Liver warning:

This product contains acetaminophen. Severe liver damage may occur if your child takes

  • •
    more than 5 doses in 24 hours, which is the maximum daily amount
  • •
    with other drugs containing acetaminophen

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.

For rectal use only

Directions
  • •
    this product does not contain directions or warnings for adult use
  • •
    do not use more than directed
  • •
    remove wrapper
  • •
    carefully insert suppository well up into the rectum

Dosing Chart

Age

Dose

under 3 years

Do not use unless directed by a doctor

3 to 6 years

Use 1 suppository every 4 to 6 hours (maximum of 5 doses in 24 hours)
Do Not Use
  • •
    if you are allergic to acetaminophen
  • •
    with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Other Information
  • •
    store at 20-25°C (68-77°F) or in a cool place
  • •
    tamper-evident: suppositories are individually wrapped. Do not use if printed wrapper is opened or damaged.
Inactive Ingredient

hydrogenated vegetable oil

Questions Or Comments?

Call 833-358-6431 Monday to Friday 9:00am to 7:00pm EST

Principal Display Panel

Foster & Thrive™

COMPARE TO FeverAll® ACTIVE INGREDIENT

FOR CHILDREN

Pain Reliever

Acetaminophen Suppositories 120 mg

ACTUAL SIZE

PAIN RELIEVER/FEVER REDUCER

Ages 3-6 years

SEE NEW WARNING

12 RECTAL SUPPOSITORIES, 120 mg EACH

Ask A Doctor Before Use If
  • •
    the child has liver disease
  • •
    the child is taking the blood thinning drug warfarin
Stop Use and Ask A Doctor If
  • •
    fever lasts more than 3 days (72 hours), or recurs
  • •
    pain lasts more than 5 days or gets worse
  • •
    new symptoms occur
  • •
    redness or swelling is present in the painful area.

These may be signs of a serious condition.

Keep Out of Reach of Children.

If swallowed or in case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical in case of overdose for adults and for children even if you do not notice any signs or symptoms.

Active Ingredient (in Each Rectal Suppository)

Acetaminophen 120 mg

Structured Label Content

Uses

temporarily

  • •
    reduces fever
  • •
    relieves minor aches, pains, and headache
Purposes

Pain reliever/fever reducer

Warnings

Liver warning:

This product contains acetaminophen. Severe liver damage may occur if your child takes

  • •
    more than 5 doses in 24 hours, which is the maximum daily amount
  • •
    with other drugs containing acetaminophen

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.

For rectal use only

Directions
  • •
    this product does not contain directions or warnings for adult use
  • •
    do not use more than directed
  • •
    remove wrapper
  • •
    carefully insert suppository well up into the rectum

Dosing Chart

Age

Dose

under 3 years

Do not use unless directed by a doctor

3 to 6 years

Use 1 suppository every 4 to 6 hours (maximum of 5 doses in 24 hours)
Do Not Use (Do not use)
  • •
    if you are allergic to acetaminophen
  • •
    with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Other Information (Other information)
  • •
    store at 20-25°C (68-77°F) or in a cool place
  • •
    tamper-evident: suppositories are individually wrapped. Do not use if printed wrapper is opened or damaged.
Inactive Ingredient (Inactive ingredient)

hydrogenated vegetable oil

Questions Or Comments? (Questions or comments?)

Call 833-358-6431 Monday to Friday 9:00am to 7:00pm EST

Principal Display Panel

Foster & Thrive™

COMPARE TO FeverAll® ACTIVE INGREDIENT

FOR CHILDREN

Pain Reliever

Acetaminophen Suppositories 120 mg

ACTUAL SIZE

PAIN RELIEVER/FEVER REDUCER

Ages 3-6 years

SEE NEW WARNING

12 RECTAL SUPPOSITORIES, 120 mg EACH

Ask A Doctor Before Use If (Ask a doctor before use if)
  • •
    the child has liver disease
  • •
    the child is taking the blood thinning drug warfarin
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • •
    fever lasts more than 3 days (72 hours), or recurs
  • •
    pain lasts more than 5 days or gets worse
  • •
    new symptoms occur
  • •
    redness or swelling is present in the painful area.

These may be signs of a serious condition.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed or in case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical in case of overdose for adults and for children even if you do not notice any signs or symptoms.

Active Ingredient (in Each Rectal Suppository) (Active ingredient (in each rectal suppository))

Acetaminophen 120 mg

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:52.234335 · Updated: 2026-03-14T23:08:17.487612