children’s pain and fever chewables acetaminophen

children’s pain and fever chewables acetaminophen
SPL v9
SPL
SPL Set ID b416857a-22d5-4504-9bbc-69ab5429654d
Route
oral
Published
Effective Date 2025-10-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
acetaminophen (160 mg)
Inactive Ingredients
citric acid monohydrate crospovidone (120 .mu.m) d&c red no. 30 dextrose, unspecified form hydroxypropyl cellulose, unspecified magnesium stearate maltodextrin silicon dioxide carboxymethylcellulose sodium, unspecified starch, corn sucralose

Identifiers & Packaging

Pill Appearance
Imprint: RP160 Shape: round Color: pink Size: 16 mm Score: 2
Marketing Status
otc monograph drug active Since 2020-01-29

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 160 mg


Medication Information

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 reaction. Symptom may include:

  • skin reddening
  • blister
  • rash
  • If a skin reaction occurs, stop use and seek medical help right away.
Uses
  • temporarily relieves minor aches and pains due to:
    • the common cold
    • flu
    • headache
    • sore throat
    • toothache
  • temporarily reduces fever
Purpose

Pain reliever/fever reducer

Directions
  • this product does not contain directions or complete warnings for adult use.
  • do not give more than directed (see overdose warning)
  • find the right dose on chart below. If possible, use weight to dose; otherwise use age.
  • chew completely do not swallow whole
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours

Weight (lbs)

under 24

24-35

36-47

48-59

60-71

72-95

Age (yr)

under 2 years

2-3 years

 4-5 years

6-8 years

9-10 years

11 years

Dose (tablets)*

 ask a doctor

1 tablet

1 ½ tablets

2 tablets

2 ½ tablets

3 tablets

Other Information
  • store at room temperature. Avoid high humidity. Protect from light.
  • see end flap for expiration date and lot number
Inactive Ingredients

citric acid, crospovidone, D&C Red No. 30, dextrose, flavor, hydroxypropylcellulose, magnesium stearate, maltodextrin, silicon dioxide, sodium carboxymethylcellulose, starch, sucralose.

Description

Acetaminophen 160 mg

Principal Display Panel

NDC 41250-246-24

Compare to active ingredient in Children’s Tylenol® Chewables*

Children’s

Pain + Fever Chewables

Acetaminophen 160 mg each

Pain reliever/Fever reducer

Aspirin free

Ibuprofen free

AGES 2-11

Bubblegum Flavor

Naturally and Artificially Flavored

24 Chewable Tablets – 160 mg each

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Children’s Tylenol® Chewables.

IMPORTANT:Keep this carton for future reference on full labeling.

Distributed by:

MEIJER DISTRIBUTION INC

GRAND RAPIDS, MI, 49544

www.meijer.com

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 your child is allergic to acetaminophen or any of the inactive ingredients in this product.
Sore Throat Warning:

If sore throat is severe, persists for more than 2 days is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Questions Or Comments?

1-866-467-2748

When Using This Product

do not exceed recommended dose (see overdose warning)

Stop Use and Ask A Doctor If
  • pain gets worse or lasts more than 5 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.

Keep Out of Reach of Children.

Overdose warning:In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical even if you do not notice any signs or symptoms.

Ask A Doctor Before Use If Your Child Has

liver disease.

Active Ingredient (in Each Chewable Tablet)

Acetaminophen 160 mg

Ask A Doctor Or Pharmacist Before Use If Your Child Is

taking the blood thinning drug warfarin.


Structured Label Content

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 reaction. Symptom may include:

  • skin reddening
  • blister
  • rash
  • If a skin reaction occurs, stop use and seek medical help right away.
Uses
  • temporarily relieves minor aches and pains due to:
    • the common cold
    • flu
    • headache
    • sore throat
    • toothache
  • temporarily reduces fever
Purpose

Pain reliever/fever reducer

Directions
  • this product does not contain directions or complete warnings for adult use.
  • do not give more than directed (see overdose warning)
  • find the right dose on chart below. If possible, use weight to dose; otherwise use age.
  • chew completely do not swallow whole
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours

Weight (lbs)

under 24

24-35

36-47

48-59

60-71

72-95

Age (yr)

under 2 years

2-3 years

 4-5 years

6-8 years

9-10 years

11 years

Dose (tablets)*

 ask a doctor

1 tablet

1 ½ tablets

2 tablets

2 ½ tablets

3 tablets

Other Information (Other information)
  • store at room temperature. Avoid high humidity. Protect from light.
  • see end flap for expiration date and lot number
Inactive Ingredients (Inactive ingredients)

citric acid, crospovidone, D&C Red No. 30, dextrose, flavor, hydroxypropylcellulose, magnesium stearate, maltodextrin, silicon dioxide, sodium carboxymethylcellulose, starch, sucralose.

Principal Display Panel

NDC 41250-246-24

Compare to active ingredient in Children’s Tylenol® Chewables*

Children’s

Pain + Fever Chewables

Acetaminophen 160 mg each

Pain reliever/Fever reducer

Aspirin free

Ibuprofen free

AGES 2-11

Bubblegum Flavor

Naturally and Artificially Flavored

24 Chewable Tablets – 160 mg each

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Children’s Tylenol® Chewables.

IMPORTANT:Keep this carton for future reference on full labeling.

Distributed by:

MEIJER DISTRIBUTION INC

GRAND RAPIDS, MI, 49544

www.meijer.com

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 your child is allergic to acetaminophen or any of the inactive ingredients in this product.
Sore Throat Warning: (Sore throat warning:)

If sore throat is severe, persists for more than 2 days is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Questions Or Comments? (Questions or comments?)

1-866-467-2748

When Using This Product (When using this product)

do not exceed recommended dose (see overdose warning)

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • pain gets worse or lasts more than 5 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.

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 at 1-800-222-1222. Quick medical attention is critical even if you do not notice any signs or symptoms.

Ask A Doctor Before Use If Your Child Has (Ask a doctor before use if your child has)

liver disease.

Active Ingredient (in Each Chewable Tablet) (Active ingredient (in each chewable tablet))

Acetaminophen 160 mg

Ask A Doctor Or Pharmacist Before Use If Your Child Is (Ask a doctor or pharmacist before use if your child is)

taking the blood thinning drug warfarin.


Advanced Ingredient Data


Raw Label Data

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