Children's Acetaminophen Chewable Tablets

Children's Acetaminophen Chewable Tablets
SPL v3
SPL
SPL Set ID d89fd9d8-d88e-3968-e053-2a95a90afc5f
Route
ORAL
Published
Effective Date 2022-08-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (80 mg)
Inactive Ingredients
Glycerin Palm Oil Xylitol Guar Gum Maltodextrin Glyceryl Dibehenate Calcium Carbonate Citric Acid Monohydrate Stevia Rebaudiuna Leaf Lecithin, Sunflower Carnauba Wax Dextrose Acacia

Identifiers & Packaging

Pill Appearance
Imprint: G10 Shape: round Color: white Size: 20 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-02-28

Description

Drug Facts


Medication Information

Warnings and Precautions

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.

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.

Indications and Usage

Uses

  • temporarily relieves minor aches and pains due to:
  • the common cold
  • sore throat
  • flu
  • toothache
  • headache
  • temporarily reduces fever
Dosage and Administration

Directions

  • this product does not contain directions or complete warnings for adult use.
  • do not give more than directed (see Overdose warning)
  • find right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • chew tablets completely before swallowing; do not swallow tablets whole
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
Weight Age Dose
Under 24 lbs. Under 2 years Ask a doctor
24-35 lbs. 2-3 years 2 tablets
36-47 lbs. 4-5 years 3 tablets
48-59 lbs. 6-8 years 4 tablets
60-71 lbs. 9-10 years 5 tablets
72-95 lbs. 11 years 6 tablets

or as directed by a doctor

Description

Drug Facts

Section 34088-5

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50566-9

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.

Section 50567-7

When using this product do not exceed recommended dose (see Overdose warning)

Section 50568-5

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin

Section 50569-3

Ask a doctor before use if your child has liver disease

Section 50570-1

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

Section 51727-6

Inactive ingredients

acacia gum‡, calcium carbonate‡, organic carnauba wax, cellulose‡, citric acid‡, dextrose‡, dibehenin (vegetable source)‡, flavor‡, glycerin‡, grape flavor‡, organic guar gum, maltodextrin‡, organic palm olein, organic stevia rebaudiana leaf extract, organic

sunflower lecithin, xylitol‡

‡ natural

Section 51945-4

Children's

Genexa®

MEDICINE MADE CLEAN

Ages 2-11

Acetaminophen Chewables

Pain Reliever Fever Reducer

How we're different

Made without: crospovidone, D&C red no. 30 aluminum lake, sucralose & more!

Read our label vs. Children's Tylenol® Chewables Grape*

24 Chewable Tablets

80 mg each

Grape Flavor

Section 53413-1

Questions? 1-855-436-3921

Section 55105-1

Purpose

Pain reliever/fever reducer

Section 55106-9

Active ingredient (in each tablet)

Acetaminophen 80 mg

Section 60561-8

Other information

  • each tablet contains: calcium 10 mg
  • store between 20-25°C (68-77°F). Avoid high humidity. Protect from light.

Structured Label Content

Indications and Usage (34067-9)

Uses

  • temporarily relieves minor aches and pains due to:
  • the common cold
  • sore throat
  • flu
  • toothache
  • headache
  • temporarily reduces fever
Dosage and Administration (34068-7)

Directions

  • this product does not contain directions or complete warnings for adult use.
  • do not give more than directed (see Overdose warning)
  • find right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • chew tablets completely before swallowing; do not swallow tablets whole
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
Weight Age Dose
Under 24 lbs. Under 2 years Ask a doctor
24-35 lbs. 2-3 years 2 tablets
36-47 lbs. 4-5 years 3 tablets
48-59 lbs. 6-8 years 4 tablets
60-71 lbs. 9-10 years 5 tablets
72-95 lbs. 11 years 6 tablets

or as directed by a doctor

Warnings and Precautions (34071-1)

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.

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.

Section 34088-5 (34088-5)

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

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.

Section 50567-7 (50567-7)

When using this product do not exceed recommended dose (see Overdose warning)

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin

Section 50569-3 (50569-3)

Ask a doctor before use if your child has liver disease

Section 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

Inactive ingredients

acacia gum‡, calcium carbonate‡, organic carnauba wax, cellulose‡, citric acid‡, dextrose‡, dibehenin (vegetable source)‡, flavor‡, glycerin‡, grape flavor‡, organic guar gum, maltodextrin‡, organic palm olein, organic stevia rebaudiana leaf extract, organic

sunflower lecithin, xylitol‡

‡ natural

Section 51945-4 (51945-4)

Children's

Genexa®

MEDICINE MADE CLEAN

Ages 2-11

Acetaminophen Chewables

Pain Reliever Fever Reducer

How we're different

Made without: crospovidone, D&C red no. 30 aluminum lake, sucralose & more!

Read our label vs. Children's Tylenol® Chewables Grape*

24 Chewable Tablets

80 mg each

Grape Flavor

Section 53413-1 (53413-1)

Questions? 1-855-436-3921

Section 55105-1 (55105-1)

Purpose

Pain reliever/fever reducer

Section 55106-9 (55106-9)

Active ingredient (in each tablet)

Acetaminophen 80 mg

Section 60561-8 (60561-8)

Other information

  • each tablet contains: calcium 10 mg
  • store between 20-25°C (68-77°F). Avoid high humidity. Protect from light.

Advanced Ingredient Data


Raw Label Data

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