Children’s Pain Fever Chewables Acetaminophen 24 Melty Tabs

Children’s Pain Fever Chewables Acetaminophen 24 Melty Tabs
SPL v8
SPL
SPL Set ID 0dd643a4-3cbc-423d-95b4-ba373b09d895
Route
ORAL
Published
Effective Date 2025-01-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (160 mg)
Inactive Ingredients
Citric Acid Monohydrate Starch, Corn Crospovidone (120 .mu.m) D&c Red No. 30 Dextrose, Unspecified Form Ethylcellulose, Unspecified Fd&c Blue No. 1 Gelatin, Unspecified Maltodextrin Magnesium Stearate Sucralose

Identifiers & Packaging

Pill Appearance
Imprint: RP160 Shape: round Color: purple Size: 16 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-11-11

Description

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 160 mg

Uses
  • temporarily relieves minor aches and pains due to:
    • the common cold
    • flu
    • headache
    • sore throat
    • toothache
  • temporarily reduces fever
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. Symptoms may include:

  • skin reddening
  • blister
  • rash

If a skin reaction occurs, stop use and seek medical help right away

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.

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 or as directed by a doctor

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

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.
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 Lake, dextrose, FD&C Blue No. 1 Lake, flavors, hydroxypropylcellulose, magnesium stearate, maltodextrin, silicon dioxide, sodium carboxymethyl cellulose, starch, sucralose

Questions Or Comments?

1-866-467-2748

Principal Display Panel

NDC 11673-241-24

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

children’s acetaminophen

chewable tabs, 160 mg

up & up

pain reliever/fever reducer

aspirin free

ibuprofen free

Ages 2-11 YEARS

GRAPE 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

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

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

50844 REV0213F44908

094 01 0603 R03 ID225450

Distributed by Target Corporation

Minneapolis,MN 55403

© 2019 Target Brands,Inc.

Shop Target.com

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

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

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. Symptoms may include:

  • skin reddening
  • blister
  • rash

If a skin reaction occurs, stop use and seek medical help right away

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.

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 or as directed by a doctor

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

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.
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 Lake, dextrose, FD&C Blue No. 1 Lake, flavors, hydroxypropylcellulose, magnesium stearate, maltodextrin, silicon dioxide, sodium carboxymethyl cellulose, starch, sucralose

Questions Or Comments? (Questions or comments?)

1-866-467-2748

Principal Display Panel

NDC 11673-241-24

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

children’s acetaminophen

chewable tabs, 160 mg

up & up

pain reliever/fever reducer

aspirin free

ibuprofen free

Ages 2-11 YEARS

GRAPE 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

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

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

50844 REV0213F44908

094 01 0603 R03 ID225450

Distributed by Target Corporation

Minneapolis,MN 55403

© 2019 Target Brands,Inc.

Shop Target.com

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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